Methods and apparatus for increasing and/or for monitoring a party&#39;s compliance with a schedule for taking medicines

ABSTRACT

Methods and apparatus are provided for increasing and/or monitoring a party&#39;s compliance with a schedule for taking medicines. In a first embodiment, a method is provided for use by a first container that is adapted to store a first medicine. The method includes storing information regarding the first medicine and wirelessly communicating a signal between the first container and a second container adapted to store a second medicine. In a second embodiment, a method is provided that includes determining if a first container for storing a first medicine is positioned so as to wirelessly communicate with a second container for storing a second medicine. The method further includes generating data based at least in part on whether the first container is positioned so as to wirelessly communicate with the second container. In a third embodiment, a method is provided that includes receiving a signal and, based at least in part on the received signal, determining whether a first container for storing a first medicine was positioned so as to wirelessly communicate with a second container for storing a second medicine. In a fourth embodiment, a method is provided that includes receiving a signal from a device that monitors whether a first container for storing a first medicine and a second container for storing a second medicine are positioned so as to communicate. The method further includes determining if at least one party has complied with a schedule for taking the first medicine and the second medicine based at least in part on the received signal. Systems, apparatus and computer program products are provided for carrying out the above-described embodiments and numerous other embodiments.

CROSS-REFERENCE TO RELATED U.S. APPLICATIONS

This application is continuation of U.S. patent application Ser. No.09/609,253, filed Jun. 30, 2000, entitled “METHODS AND APPARATUS FORINCREASING AND/OR FOR MONITORING A PARTY'S COMPLIANCE WITH A SCHEDULEFOR TAKING MEDICINES”;

which claims priority from U.S. Provisional Patent Application Ser. No.60/188,279, filed Mar. 10, 2000.

This application is related to U.S. patent application Ser. No.09/165,089, filed Oct. 1, 1998, titled “Method and Apparatus ForDocumenting Cap Removal Data”, now U.S. Pat. No. 6,751,730 B1, thecontent of which is hereby incorporated by reference herein in itsentirety.

This application also is related to U.S. patent application Ser. No.09/609,017, filed Jun. 30, 2000 titled “Methods and Apparatus forIncreasing, Monitoring and/or Rewarding a Party's Compliance with aSchedule for Taking Medicines”) the content of which is herebyincorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to healthcare, and morespecifically to methods and apparatus for increasing and/or formonitoring a party's compliance with a schedule for taking medicines.

BACKGROUND OF THE INVENTION

The deleterious consequences of a patient's failure to comply with aprescribed schedule for taking one or more medicines (i.e., patientnon-compliance) have long been recognized, and are predominantlymanifested in terms of human costs and monetary costs. Human costsassociated with patient non-compliance include, for example, poorhealth, death, a lengthened healing process and/or the emergence of newand drug-resistant strains of viruses/bacteria. Accompanying medicalcosts include, for example, hospitalization expenses, surgery expensesand/or increased insurance expenses. A seven thousand person per yeardeath rate of Americans and a $100 billion annual toll on the Americanhealthcare system have been attributed to patient non-compliance (see,the November 1999 report of the Institute of Medicine of the NationalAcademy of Sciences, and Healthcare PR & Marketing News, vol. 8, no. 18,Sep. 2, 1999, respectively).

The main reasons for patient non-compliance are well known. Patientnon-compliance occurs, for example, because a patient forgets to takeone or more medicines, forgets to abide by various rules for taking oneor more medicines, misinterprets rules for taking one or more medicines,or does not want to take one or more medicines (e.g., because taking themedicines is a nuisance, because of adverse side effects associated withone or more medicines, etc.). Also, patient non-compliance may occurbecause a patient does not feel that one or more medicines are necessary(e.g., because the patient feels better, because the patient does notfeel any immediate effects of taking/not taking a medicine, because amedicine is merely a preventative medicine such as hypertensionmedication, etc.), because the patient cannot afford the medicine,because the patient runs out of medicine before obtaining a refill, orthe like.

Patient non-compliance typically becomes more pronounced when a patienttakes many medicines. For example, a schedule for taking six medicinesis more difficult to adhere to than a schedule for taking only twomedicines. The dangers and/or the risks associated with patientnon-compliance also increase with the number of medicines to be taken(e.g., due to potential adverse medicine interactions amongst themedicines).

To combat patient non-compliance, numerous conventionaltechniques/systems have been employed. For example, as an attempt atpreventing a customer from taking incompatible medicines, a pharmacy maytrack prescribed medicines that the pharmacy fills for the customer.Likewise, a doctor may track each medicine that the doctor prescribesfor a patient. However, pharmacists and doctors have difficulty trackingthe actual consumption of medicines and/or encouraging adherence to amedicine schedule (e.g., because pharmacists/doctors typically do notmeet with customer/patients on a daily basis).

Other conventional techniques/systems for combating patientnon-compliance include, for example, medicine containers thatcommunicate with a central device to provide reminders and warnings topatients regarding when medicines should or should not be taken, devicesthat dispense one or more medicines at a time and then issuereminders/warnings to patients regarding the dispensed medicines, etc.Other conventional devices may record patient compliance information(e.g., when a medicine was taken) and may communicate (or allow apatient to communicate) such information to a healthcare facility orinsurance company (e.g., to allow the healthcare facility or insurancecompany to monitor patient compliance). For example, previouslyincorporated U.S. patent application Ser. No. 09/165,089, filed Oct. 1,1998, which is now U.S. Pat. No. 6,751,730 B1, discloses a system thatdocuments and authenticates cap removal data (e.g., the number of timesthat a patient removes the cap of a medicine container), so that the capremoval data may be reliably provided to a third party (e.g., aninsurance company).

Despite the prevalence of techniques/systems for combating patientnon-compliance and for monitoring patient non-compliance, patientnon-compliance remains a significant drain on the healthcare industry.Accordingly, a need exists for improved methods and apparatus forincreasing and/or for monitoring a party's compliance with a schedulefor taking medicines.

SUMMARY OF THE INVENTION

To overcome the drawbacks of the prior art, novel methods and apparatusare provided for increasing and/or for monitoring a party's compliancewith a schedule for taking medicines. In a first embodiment, a novelmethod is provided for use by a first container that is adapted to storea first medicine. The method includes storing information regarding thefirst medicine and wirelessly communicating a signal between the firstcontainer and a second container adapted to store a second medicine. Asused herein “wirelessly” communicating means communicating without theuse of a physical connection such as an electrical wire (e.g., via aradio frequency (RF) signal.

In one or more embodiments, the method may farther include: (1)transmitting information regarding the first medicine from the firstcontainer to the 30 second container and/or transmitting informationregarding the second medicine from the second container to the firstcontainer; (2) receiving information regarding a schedule for taking atleast one of the first medicine and the second medicine; (3) detectingif a portion of the first medicine has been removed from the firstcontainer and/or detecting if a portion of the second medicine has beenremoved from the second container; (4) detecting if a party attempts totake the first medicine within a predetermined time period of taking thesecond medicine (and vice versa) and generating a warning if the firstmedicine is incompatible with the second medicine; (5) transmitting anindicator of the warning to at least one of a representative of aninsurance company, a representative of a pharmacy and a representativeof a medical facility; (6) generating at least one code based at leastin part on the signal communicated between the first and the secondcontainers, the at least one code indicating whether at least one partyhas complied with a schedule for taking the first medicine and thesecond medicine; and/or (7) outputting the at least one code to at leastone of a representative of an insurance company, a representative of apharmacy and a representative of a medical facility. Accordingly, in atleast one embodiment of the invention, one or more containers forstoring one or more medicines (i.e., medicine containers) may generate awarning if a party attempts to take incompatible medicines together (orwithin a predetermined time period of one another). Also, one or moremedicine containers may notify a representative of an insurance company,a representative of a pharmacy, a representative of a medical facilityor any other entity if a party has complied with (or has failed tocomply with) a schedule for taking medicines. As used herein, a“representative” may be, for example, any person (e.g., an employee, asubcontractor, an agent, an objective third party, etc.) or anycommunications device (e.g., a computer, a facsimile machine, atelephone, a pager, etc.).

In a second embodiment, a method is provided that includes determiningif a first container for storing a first medicine is positioned so as towirelessly communicate with a second container for storing a secondmedicine. The method further includes generating data based at least inpart on whether the first container is positioned so as to wirelesslycommunicate with the second container.

In a third embodiment, a method is provided that includes receiving asignal and, based at least in part on the received signal, determiningwhether a first container for storing a first medicine was positioned soas to wirelessly communicate with a second container for storing asecond medicine.

In a fourth embodiment, a method is provided that includes receiving asignal from a device that monitors whether a first container for storinga first medicine and a second container for storing a second medicineare positioned so as to communicate. The method further includesdetermining if at least one party has complied with a schedule fortaking the first medicine and the second medicine based at least in parton the received signal.

In a fifth embodiment, a method is provided for rewarding a party forcomplying with a medicine schedule. The method includes receivinginformation regarding whether at least two medicine containers were ableto communicate during a pre-determined time period, and determining alevel to which the party complied to a medicine schedule based on theinformation. The method further includes rewarding the party based onthe party's level of compliance.

Systems, apparatus and computer program products are provided forcarrying out the above-described embodiments and numerous otherembodiments of the present invention. Each computer program productdescribed herein may be carried by a medium readable by a computer(e.g., a carrier wave signal, a floppy disc, a hard drive, a randomaccess memory, etc.).

In one or more embodiments, an apparatus is provided for monitoringwhether a party has complied with a schedule for taking medicines. Theapparatus includes first storage means for storing a first medicine andmeans for wirelessly communicating a signal between the first storagemeans and second storage means for storing a second medicine.

With these and other advantages and features of the invention that willbecome hereinafter apparent, the nature of the invention may be moreclearly understood by reference to the following detailed description ofthe invention, to the appended claims and to the several drawingsattached herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is described with reference to the accompanyingdrawings. In the drawings, like reference numbers indicate identical orfunctionally similar elements.

FIG. 1A is a schematic diagram of a novel compliance system forincreasing a party's compliance to a medicine schedule and formonitoring the party's compliance to a medicine schedule;

FIG. 1B illustrates an embodiment of the novel compliance system of FIG.1A wherein a compliance monitoring device of the novel compliance systemis a medicine container;

FIG. 1C illustrates an embodiment of the novel compliance system of FIG.1A wherein a compliance monitoring device of the novel compliance systemis a meta-container;

FIG. 1D illustrates an embodiment of the novel compliance system of FIG.1A wherein a compliance monitoring device of the novel compliance systemis a mini-container;

FIG. 1E illustrates an embodiment of the novel compliance system of FIG.1A wherein a compliance monitoring device of the novel compliance systemmay be in communication with a controller of the novel compliancesystem;

FIG. 2 is a schematic diagram of an exemplary embodiment of a controllerof the novel compliance system of FIGS. 1A-1E;

FIG. 3 illustrates a sample of the contents of a patient database of thecontroller of FIG. 2;

FIG. 4 illustrates a sample of the contents of a prescription databaserecord of a prescription database of the controller of FIG. 2;

FIG. 5 illustrates a sample of the contents of a reward database of thecontroller of FIG. 2;

FIG. 6 illustrates a sample of the contents of a compliance database ofthe controller of FIG. 2;

FIG. 7A is a schematic diagram of a first exemplary embodiment of acompliance monitoring device of the novel compliance system of FIG. 1B;

FIG. 7B is a schematic diagram of a second exemplary embodiment of acompliance monitoring device of the novel compliance system of FIGS.1C-1D;

FIG. 8 illustrates a sample of the contents of a container databaserecord of a container database of the compliance monitoring devices ofFIGS. 7A and 7B.

FIG. 9 is a flow chart of a first exemplary process of the novelcompliance system of FIGS. 1A-8;

FIG. 10 is a flow chart of a first exemplary process by which acompliance monitoring device of the novel compliance system of FIGS.1A-8 monitors and tracks the compliance of a patient to a schedule fortaking medicines;

FIG. 11 is a flow chart of a second exemplary process by which acompliance monitoring device of the novel compliance system of FIGS.1A-8 monitors and tracks the compliance of a patient to a schedule fortaking medicines;

FIG. 12 is a flow chart of a first exemplary process by which acontroller of the novel compliance system of FIGS. 1A-8 receivescompliance data from a patient and rewards the patient based on thereceived compliance data; and

FIG. 13 is a flow chart of a second exemplary process by which acontroller of the novel compliance system of FIGS. 1A-8 receivesproximity information from a patient and rewards the patient based onthe received proximity information,

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a novel compliance system that canincrease a party's compliance to a schedule for taking medicines (“amedicine schedule”) and that allows the party's compliance to themedicine schedule to be easily monitored. Novel methods, apparatus andcomputer program products also are provided.

RELEVANT TERMINOLOGY

As used herein, the term “medicine” refers to any prescription ornon-prescription medication, dietary supplement, herbal remedy, vitamin,mineral, etc. A medicine may be in any state of matter (e.g., solid,liquid, gas or any combination thereof) and may include a combination ofone or more medicines. A medicine may be “taken” by any known mechanism(e.g., oral consumption, injection, transdermally, etc.), and a partymay “take” a medicine whether or not the medicine is delivered by theparty (e.g., a patient may “take” a medicine if the medicine is injectedinto the patient by a third party, whether or not the patient isconscious). A container for storing a medicine may include any suitablecontainer (e.g., a pill bottle, a pill box, a vial, a syringe, a foilpacket, etc.).

OVERVIEW OF THE INVENTIVE COMPLIANCE SYSTEM

As stated, the inventive compliance system can increase a party'scompliance to a medicine schedule and allow the party's compliance tothe medicine schedule to be easily monitored. For example, an insurancecompany may employ one or more embodiments of the invention to receiveauthenticated information regarding a patient's compliance to a medicineschedule, to track (e.g., monitor over time) the patient's compliance tothe medicine schedule and/or to reward the patient based on the level towhich the patient complies with the medicine schedule (e.g., so as tomotivate the patient to comply through use of positive reinforcement).Numerous rewarding schemes are provided such as monetary rewards,multi-tiered rewards (e.g., different rewards based on the type ofcompliance a patient exhibits as described below), prizes, etc.

As will be described below with reference to FIGS. 9-13, any indicator(or any number of indicators) of compliance may be monitored and/ortracked with the present invention. For example, an insurance companymay monitor a party's compliance with a schedule for taking onemedicine, a party's compliance with a schedule for taking multiplemedicines, a party's compliance with a requirement that two or moremedicine containers be kept within a certain distance or range of oneanother (e.g., a “proximity requirement”), that multiple parties havesatisfied any of the above-described compliance requirements, and/or anyother compliance requirements.

Specific embodiments of the invention aid a party in complying with amedicine schedule by: (1) notifying the party when the party should takeone or more medicines (e.g., so as to satisfy the medicine schedule) orshould not take one or more medicines (e.g., because one or moremedicines are incompatible and may harm the party if taken together);(2) reminding the party to obtain a refill of a medicine if the partyhas consumed all or most of the medicine; and/or (3) assisting the partyin locating a medicine container (e.g., if the party has misplaced themedicine container).

In one or more embodiments of the invention, a party obtains a pluralityof medicine containers that are capable of wirelessly communicating withone another, that each store a medicine, and that are each programmedwith information regarding the medicine stored within the medicinecontainer. Other information such as medicine compatibility informationalso may be stored within each medicine container as described belowwith reference to FIG. 7A and FIG. 8. For example, each medicinecontainer may be programmed with all of the information necessary forthe medicine container to be “self-regulating” (e.g., by communicatingwith other medicine containers). That is, in at least one embodiment ofthe invention, each medicine container may communicate information toother medicine containers that indicates when medicine was removed fromthe medicine container, each medicine container may receive informationthat indicates when medicine was removed from other medicine containers,and each medicine container may determine, based on a schedule fortaking medicines and/or based on incompatibility information aboutmedicines, whether a party should take a medicine stored within themedicine container. For “self-regulating” medicine containers, aninsurance company may track compliance to a medicine schedule merely bymonitoring whether the medicine containers are being kept together.

As an example of the use of “self-regulating” medicine containers,assume that a doctor prescribes three medicines to a patient, and thatthe patient obtains the three medicines from a local pharmacy. When thepharmacy fills the prescriptions for the three medicines, instead ofemploying a conventional “pill bottle” for each medicine, the pharmacyemploys three of the inventive, self regulating medicine containers tostore each prescribed medicine. Exemplary embodiments of such selfregulating medicine containers are described below with reference toFIG. 7A.

In addition to placing each medicine in each medicine container, thepharmacy “programs” each medicine container with information regardingthe medicine to be stored within the container (e.g., via RFcommunications, via a serial or parallel port, or via any other means asdescribed below with reference to FIG. 7A). The informationprogrammed/stored within each medicine container may include, forexample, a schedule for taking the medicine stored within the medicinecontainer, information regarding the compatibility/incompatibility ofthe medicine stored within the medicine container relative to the othertwo medicines and/or any other medicines taken by the patient, and anyother relevant information. Thereafter, the three medicine containersmay communicate amongst one another, exchanging information such as wheneach medicine stored within each medicine container should be taken, isabout to be taken, is being taken or has been taken, and alerting thepatient when the patient should take each medicine (e.g., to comply witha medicine schedule) or should not take each medicine (e.g., due toincompatibility amongst two or more of the medicines).

One of the medicine containers may serve as a “compliance monitoringdevice” that monitors/tracks, for example, the proximity of the medicinecontainers (e.g., whether the medicine containers are positioned so asto communicate), each time a party takes a medicine, the dose of eachmedicine taken by a party, etc. Alternatively, a separate centralmonitoring device (e.g., a device that does not function as a medicinecontainer) may be employed as a compliance monitoring device tomonitor/track the above information.

After obtaining the above information, the compliance monitoring devicemay provide data to a controller (e.g., employed by the insurancecompany) that includes, for example, (1) information regarding theproximity of the medicine containers (e.g., the times the medicinecontainers were separated and could not communicate, the times themedicine containers were together and could communicate, etc.); (2) oneor more levels to which a party has complied with a proximityrequirement for the medicine containers (e.g., a proximity requirementset by an insurance company, such as a pre-determined, maximum timeperiod that the medicine containers may be separated); (3) informationregarding the medicines taken by a party (e.g., the amount of eachmedicine taken by the party, the time each medicine was taken by theparty, etc.); and/or (4) one or more levels to which a party hascomplied with one or more schedules for taking the medicines storedwithin the medicine containers (e.g., a level to which the party hascomplied with a schedule for taking each medicine, a level to which theparty has complied with a schedule for taking multiple medicines, etc.).

Depending on the data received by the controller, the controller mayreward the party directly (e.g., if the data provided by the compliancemonitoring device includes one or more levels of compliance that weredetermined by the compliance monitoring device), or the controller mayemploy the received data to determine one or more levels of compliancefor the party (and may then reward the party).

Note that the present invention provides numerous advantages over theprior art. Through use of one or more embodiments of the presentinvention, the probability that a party will comply with a schedule fortaking medicines may be increased and the party's compliance to aschedule for taking medicines may be easily monitored. Unlikeconventional compliance devices, any number of medicine containersconfigured in accordance with the present invention may be incommunication (e.g., as ports or other interfaces for interconnectingmedicine containers and/or for connecting a central monitoring device tomedicine containers are not required). A highly scalable “compliancesystem” thereby may be formed through use of the present invention.

In embodiments wherein each medicine container may communicate with aplurality of other medicine containers, communications between medicinecontainers may continue even if one or more medicine containersmalfunction. Likewise, because each medicine container may be incommunication with numerous medicine containers, malfunctioning medicinecontainers are easily identified (e.g., as more than one medicine maydetect when a medicine container is malfunctioning). Because medicinecontainers need not be (but may be) physically interconnected orphysically connected to a central monitoring device, malfunctioningmedicine containers may be easily replaced.

Specific embodiments of the invention encrypt proximity and/orcompliance data that may be provided to an insurance company. In thismanner, the insurance company receives “authenticated” data that cannotbe falsified (e.g., by a patient). Other embodiments of the inventionallow an insurance company to monitor a party's compliance to a medicineschedule merely by monitoring whether two or more medicine containerswere able to communicate during a pre-determined time period.

To provide a “positive incentive” for a party to comply to a medicineschedule, embodiments of the invention allow an insurance company, adoctor, a pharmacist or any other relevant entity to convenientlymonitor the party's compliance to the medicine schedule (e.g., bymonitoring the proximity of two or more medicine containers that maycommunicate with one another), and to reward the party based on a levelto which the party complies with the medicine schedule.

Exemplary Embodiments of the Novel Compliance System

FIG. 1A is a schematic diagram of a novel compliance system 100 forincreasing a party's compliance to a schedule for taking medicines(i.e., a medicine schedule) and for monitoring the party's compliance tothe medicine schedule. The novel compliance system 100, and the othersystems described herein, are described primarily with reference to apatient's compliance to a prescribed medicine schedule (e.g., a scheduleprescribed by a physician) and to the monitoring of the patient'scompliance to the prescribed medicine schedule by a representative of aninsurance company. However, it will be understood that the presentinvention may be employed to affect any party's compliance to anymedicine schedule, and that monitoring may be performed by a familymember, by a representative of a pharmacy, by a representative of amedical facility and/or by any other party/representative.

With reference to FIG. 1A, the novel compliance system 100 includes acompliance monitoring device 102 in communication with a patient 104,and a controller 106 in communication with the patient 104 via a network108. Although only one compliance monitoring device and only one patientare shown in FIG. 1A, it will be understood that any number ofcompliance monitoring devices may be employed, that any number ofpatients (or other parties) may employ each compliance monitoringdevice, and/or that any number of patients/parties may be incommunication with the controller 106.

As described below with reference to FIGS. 1B-1E and FIGS. 7A and 7B,the compliance monitoring device 102 may comprise: (1) a medicinecontainer that is in communication with the patient 104 and/or with thecontroller 106 and that may be in wireless communication with one ormore other medicine containers; or (2) a central monitoring device thatis in communication with a medicine container (wherein the medicinecontainer may be in wireless communication with one or more othermedicine containers). For example, FIG. 1B illustrates a firstembodiment of the novel compliance system 100 wherein the compliancemonitoring device 102 is a first medicine container 102 a that is inwireless communication with a plurality of other medicine containers110-114. The compliance monitoring device 102/medicine container 102 a,and the other medicine containers 110-114, are in visual communicationwith the patient 104 (e.g., the compliance monitoring device 102/firstmedicine container 102 a displays a code (described below) thatindicates a level of compliance of the patient 104 to a schedule fortaking the medicines that are stored within the containers 102 a and110-114, the second medicine container 110 displays a message thatindicates that the second medicine container 110 is empty and must berefilled, the third medicine container 112 displays a message thatindicates that two of the pills stored within the third medicinecontainer 112 should be taken with lunch and the fourth medicinecontainer 114 displays a message that indicates that the medicine storedwithin the fourth medicine container 114 should not be taken at thepresent time because the medicine is incompatible with another medicinerecently taken or to be taken by the patient 104). The compliancemonitoring device 102/medicine container 102 a, and the other medicinecontainers 110-114, similarly may be in communication with the patient104 via audio means, tactile means, etc.

FIG. 1C illustrates a second embodiment of the novel compliance system100 wherein the compliance monitoring device 102 is a first centralmonitoring device (referred to as a “meta-container 102 b”) that may:(1) communicate with a plurality of medicine containers (e.g., medicinecontainers 102 a, 112, 114, etc.); (2) monitor when each medicinecontainer is removed from the meta-container 102 b; (3) monitor wheneach medicine container is returned to the meta-container 102 b; (4)store various information regarding the medicine within each medicinecontainer that is in communication with the meta-container 102 b; (5)store information regarding the compatibility of the medicines withinthe medicine containers that are in communication with themeta-container 102 b; and/or (6) perform any of the other compliancerelated functions described below. An exemplary embodiment for themeta-container 102 b is described below with reference to FIG. 7B.

FIG. 1D illustrates a third embodiment of the novel compliance system100 wherein the compliance monitoring device 102 is a second centralmonitoring device (referred to as a “mini-container 102 c”) that mayperform many, if not all, of the functions of the meta-container 102 bof FIG. 1C while being more portable (e.g., so that the patient 104 maytake the mini-container 102 c to work, on vacation, etc.). In at leastone embodiment, the meta-container 102 b and the mini-container 102 cmay communicate (e.g., via one or more RF transmissions or via any othermeans such as by exchanging a removable, flash memory device between themeta-container 102 b and the mini-container 102 c or by having themeta-container 102 b and the mini-container 102 c “plug” into eachother). In this manner, if the patient 104 keeps the mini-container 102c near the meta-container 102 b, the meta-container 102 b maycommunicate schedules for taking medicines, times for taking medicines,etc., to the mini-container 102 c as described further below. Anexemplary embodiment for the mini-container 102 c is described belowwith reference to FIG. 7B.

Those skilled in the art will understand that devices in communicationwith each other need only be “capable of” communicating with each otherand need not be continually transmitting data to or receiving data fromeach other. On the contrary, such devices need only transmit data to orreceive data from each other as necessary, and may actually refrain fromexchanging data most of the time. For example, a device in communicationwith another device via the Internet may not transmit data to the otherdevice or receive data from the other device for weeks at a time.Further, devices may be in communication even though steps may berequired to establish a communication link (e.g., dialing a networkservice provider, placing a medicine container within “range” of anothermedicine container and/or a central monitoring device, etc.).

The controller 106 may comprise, for example, a computer at an insurancecompany or at a medical facility, or may comprise an authenticationserver (e.g., a server that “authenticates” compliance data), asdescribed below with reference to FIG. 2. The network 108 may comprise,for example, a telephone network such as a publicly switched telephonenetwork (PSTN), a cable network, an intranet, an extranet, the Internet,an Internet-based telephone network, or any other communication medium(e.g., a radio frequency link, a microwave link, an optical link, etc.).

While the novel compliance system 100 of FIGS. 1A-1D illustrates“serial-type” communication between the compliance monitoring device 102and the controller 106, wherein the compliance monitoring device 102communicates with the patient 104, and the patient 104 communicates withthe controller 106, it will be understood that the compliance monitoringdevice 102 also may be in communication with the controller 106 as shownin FIG. 1E. For example, the compliance monitoring device 102 may be incommunication with the controller 106 via the network 108 or via adirect communication link (e.g., if the controller 106 is operated by aninsurance company, the controller 106 and/or the insurance company mayprogram the compliance monitoring device 102 with information regardingany medicines the compliance monitoring device 102 monitors/contains,and/or the insurance company may supply the compliance monitoring device102 to the patient 104).

The compliance monitoring device 102 also may be in communication withone or more medicine providers (e.g., one or more pharmacies) such as amedicine provider 116, either via the network 108 or via a directcommunication link (e.g., the medicine provider 116 may program thecompliance monitoring device 102 with information regarding anymedicines the compliance monitoring device 102 monitors/contains and maysupply the compliance monitoring device 102 to the patient 104).Likewise, the patient 104 may bring the compliance monitoring device 102to the medicine provider 116 for refilling, the medicine provider 116may obtain compliance data (or proximity information) from thecompliance monitoring device 102 (as described below), and the medicineprovider 116 may communicate the obtained data/information to thecontroller 106 (e.g., via the network 108 or by any other communicationsmedium). One or more medicine containers configured in accordance withthe present invention similarly may be in communication with thecontroller 106 and/or with the medicine provider 116.

Exemplary embodiments of the novel compliance system 100 are describedbelow with reference to FIGS. 2-13.

Exemplary Embodiments for the Controller 106

FIG. 2 is a schematic diagram of an exemplary embodiment of thecontroller 106 of FIGS. 1A-1E. The controller 106 maybe implemented as asystem controller, as a dedicated hardware circuit, as an appropriatelyprogrammed general purpose computer, or as any other equivalentelectronic, mechanical or electromechanical device.

The controller 106 comprises a processor 202, such as one or moreconventional microprocessors (e.g., one or more Intel® Pentium®processors). The processor 202 is in communication with a communicationport 204 through which the processor 202 communicates with otherdevices/parties (e.g., the compliance monitoring device 102, the patient104 and/or the medicine provider 116). The communication port 204 mayinclude multiple communication channels for simultaneous communicationwith, for example, the compliance monitoring device 102, with one ormore other compliance monitoring devices (not shown), with the patient104, with one or more other parties (not shown), with the medicineprovider 116, and/or with the one or more other medicine providers (notshown). As stated, devices in communication with each other need not becontinually transmitting to each other. On the contrary, such devicesneed only transmit to each other as necessary, may actually refrain fromexchanging data most of the time, and may require several steps to beperformed to establish a communication link between the devices.

The processor 202 also is in communication with a data storage device206. The data storage device 206 may comprise an appropriate combinationof magnetic, optical and/or semiconductor memory, and may include, forexample, Random Access Memory (RAM), Read-Only Memory (ROM), a compactdisc and/or a hard disk. The processor 202 and the data storage device206 each may be, for example, located entirely within a single computeror other computing device; or connected to each other by a communicationmedium, such as a serial port cable, a telephone line or a radiofrequency transceiver. Alternatively, the controller 106 may compriseone or more computers that are connected to a remote server computer(not shown) for maintaining databases.

In an embodiment wherein the controller 106 is employed by (e.g., isoperated by) an insurance company, the data storage device 206 maystore, for example, (i) a program 208 (e.g., computer program codeand/or a computer program product) adapted to direct the processor 202in accordance with the present invention, and particularly in accordancewith the processes described in detail hereinafter with regard to thecontroller 106; (ii) a patient database 210 adapted to store informationregarding patients that are associated with the insurance company (e.g.,patients that have an insurance policy from the insurance company);(iii) a prescription database 212 adapted to store information regardingone or more medicines that have been prescribed to a patient (e.g+, oneor more “prescriptions” of the patient) (e.g., whether a prescription is“active” or “closed”, a start date for a prescription, an end date for aprescription, etc.); (iv) a reward database 214 adapted to store a listof rewards that are available to a patient if the patient complies witha schedule for taking medicines; and (v) a compliance database 216adapted to store information regarding at least one level to which apatient has complied with a schedule for taking medicines (i.e., atleast one compliance level). The controller 106 may be similarlyconfigured for use by a medical provider, by a medical facility, etc.

The program 208 may be stored in a compressed, an uncompiled and/or anencrypted format, and may include computer program code that allows thecontroller 106 to:

-   -   1. receive a code from the patient 104 (or from the compliance        monitoring device 102) that indicates: (1) that the patient 104        has complied with a schedule for taking medicines (e.g., by        indicating a level of compliance); (2) that two or more medicine        containers (configured in accordance with the present invention        so that the two or more medicine containers may wirelessly        communicate) have been kept within a pre-determined distance of        one another during a pre-determined time period (e.g., that the        two or more medicine containers have complied with a “proximity        requirement”); and/or (3) any other compliance or proximity        information (as described below);    -   2. decrypt the code if the code is encrypted;    -   3. determine a level of compliance based on the code (e.g., if        the code merely indicates proximity information regarding two or        more medicine containers, compute a level of compliance based on        the proximity information); and    -   4. select a reward for the patient 104 based on the determined        level of compliance.        The computer program code required to implement the above        functions can be easily developed by a person of ordinary skill        in the art, and is not described in detail herein. The        controller 106 may include any peripheral devices (e.g.,        telephone keypads, handsets, headsets, microphones, speakers,        keyboards, computer displays, etc.) required to implement the        above functionality. The program 208 also may include program        elements such as an operating system, a database management        system and “device drivers” that allow the processor 202 to        interface with computer peripheral devices (e.g., a video        display, a keyboard, a mouse, etc.).

Note that instructions of the program 208 may be read into a main memory(not shown) of the processor 202 from a computer-readable medium otherthan the data storage device 206, such as from a ROM or from a RAM.While execution of sequences of instructions in program 208 causesprocessor 202 to perform the process steps described herein, hard-wiredcircuitry may be used in place of, or in combination with, softwareinstructions for implementation of the processes of the presentinvention. Thus, embodiments of the present invention are not limited toany specific combination of hardware and software.

The processor 202 also may be in communication with a clock (not shown)that supplies time and date information to the processor 202 and thatmay comprise, for example, a clock internal to the processor 202, aclock external to the processor 202 or a clock embodied within theprogram 208 (e.g., based on a system clock not shown).

Samples of the contents of the patient database 210, of the prescriptiondatabase 212, of the reward database 214 and of the compliance database216 are shown in FIGS. 3-6, respectively. The specific data and fieldsillustrated in these figures represent only one embodiment of therecords stored in the databases of the invention. The data and fields ofthese databases, as well as the number of databases, can be readilymodified, for example, to include more or fewer data fields. A singledatabase also may be employed. Note that in the databases of thecontroller 106 and in the databases of the compliance monitoring device102 (described below), a different reference numeral is employed toidentify each field of each database. However, in at least oneembodiment of the invention, fields that are similarly named (e.g.,patient identification fields, reward identification fields, etc.,described below) store similar or the same data in a similar or in thesame data format.

The patient database 210 contains information related to patients thatare associated with an insurance company that employs the controller106. FIG. 3 illustrates a sample of the contents of the patient database210. As shown in FIG. 3, the patient database 210 contains patientinformation related to three patients identified in record 302, record304 and record 306, respectively. Specifically, for each patientassociated with the insurance company (e.g., for each patient that hasan account/policy with the insurance company), the patient database 210contains records having fields corresponding to, for example, (1) apatient identifier (ID) 308, used by the controller 106 to identify thepatient; (2) a patient name 310; (3) a patient address 312; (4) apatient telephone number 314; (5) a physician 316; and (6) an indicationof whether the patient is a participant in a reward program operated bythe insurance company (described below). Other patient information notshown in FIG. 3 which may be stored within the patient database 210includes any information relevant to the controller 106's operations.

Note that the patient database 210 (and the prescription database 212,the reward database 214 and the compliance database 216) may bepopulated with data provided to the controller 106 via the communicationport 204, and that the data may be provided to the controller 106 fromthe patient 104, from a representative of the patient 104 (e.g., from afamily member), from the compliance monitoring device 102, from aninsurance company, from a pharmacy or from any other party. Thedatabases (described below) of the compliance monitoring device 102similarly populated.

The prescription database 212 contains information related toprescriptions of the patients identified in the patient database 210.FIG. 4 illustrates a sample of the contents of an exemplary record 212 aof the prescription database 212 that contains information related tothe prescriptions of a patient 402 (e.g., patient ID P-123-45-6789,which is Jane Doe of Springfield as identified by record 302 in FIG. 3).As shown in FIG. 4, the prescription database record 212 a containsinformation for four prescriptions of the patient 402 identified insub-record 404, sub-record 406, sub-record 408 and sub-record 410,respectively. Specifically the prescription database record 212 acontains sub-records having fields corresponding to, for example, (1) aprescription identifier (ID) 412 used by the controller 106 to identifyeach prescription associated with the patient 402 (e.g., eachprescription to be taken by, each prescription that is being taken byand/or each prescription that was taken by the patient 402); (2) aprescription status 414 for each prescription (e.g., “active” if theprescription is currently being taken, “pending” if the prescription isto be taken or “closed” if the prescription is no longer being-taken);(3) a start date 416 on which the patient 402 began taking eachprescription; and (4) an end date 418 on which the patient 402 stoppedtaking each prescription. Other prescription information not shown inFIG. 4 which may be stored within the prescription database record 212a, within the prescription database 212 or within any other databaseincludes, for example:

-   -   (1) the identity of each medicine (e.g., the medicine's generic        name, the medicine's brand name, an identifying code for the        medicine, etc.);    -   (2) the name of the pharmaceutical company that manufactures        each medicine;    -   (3) the prescribed method for taking each medicine (e.g., the        time of day the medicine should be taken, the number of times a        day the medicine should be taken, whether the medicine should be        taken with food, the appropriate dose of the medicine to be        taken, a time interval the patient should wait between doses, a        duration of time the patient should take the medicine, etc.);    -   (4) the purpose of each medicine (e.g., to lower blood pressure,        to thin the blood, to lower cholesterol, to reduce depression,        etc.);    -   (5) interactions of each medicine with other medicines (e.g.,        other medicines that are part of a medicine schedule of the        patient, whether the interactions are adverse or synergistic,        etc.);    -   (6) the cost of each medicine; and    -   (7) the amount of each medicine that was dispensed to the        patient (e.g., the number of pills, the net weight of the        dispensed medicine, etc.).

The reward database 214 contains information related to rewards that areavailable to a patient (identified in the patient database 210) if thepatient complies to a schedule for taking medicines. FIG. 5 illustratesa sample of the contents of the reward database 214. As shown in FIG. 5,the reward database 214 contains information for five rewards associatedwith the controller 106 (e.g., offered by an insurance company thatemploys the controller 106). The five rewards are identified in records502-510, respectively. Specifically the reward database 214 containsrecords having fields corresponding to, for example, (1) a rewardidentification (ID) 512 used by the controller 106 to identify eachreward associated with the controller 106; and (2) a reward 514identified by each reward identifier 512. As described below, whether apatient receives one of the rewards identified in records 502-510depends on a level (e.g., 100%, 80%, 92%, etc.) to which the patientcomplies to a schedule for taking medicines (e.g., a schedule for takingthe prescriptions identified for each patient in the prescriptiondatabase 212). The requisite level of compliance may be, for example,predetermined (e.g., by an insurance company) and embodied withincomputer program code of the program 208, or may be stored within adatabase (e.g., within the compliance database 216 as described below).Likewise (as described further below), a patient may receive one or moreof the rewards identified in records 502-510 merely by satisfying aproximity requirement (e.g., established by an insurance company) fortwo or more medicine containers. For example, because the medicinecontainers 102 a, 110, 112 and 114 may communicate with each other(e.g., communicate information such as when medicines were taken or areto be taken) and may issue alerts/warnings about when to take or not totake medicines, keeping the medicine containers together during apre-determined time period (e.g., at all times, during time periods whenone or more medicines are to be taken, etc.) may ensure that a patienthas complied with a medicine schedule.

Note that the rewards identified in records 502-510 are merely exemplaryand that any other rewards may be similarly employed. For example, otherrewards may include a lower insurance premium, a lower insurancedeductible, a lower insurance co-pay, a reimbursement of the cost of amedicine, a prize (e.g., a vacation, a membership at a local gym, etc.),points (e.g., an alternate currency that is redeemable for a prize ifenough points are collected), discounts on products (e.g., coupons forproducts), any of the rewards described in previously incorporated U.S.patent application Ser. No. 09/165,089, filed Oct. 1, 1998, which is nowU.S. Pat. No. 6,751,730 B1, or any other reward.

In one or more embodiments of the invention, at least one of a patient,an insurance company and a medical professional (e.g., a doctor) mayselect a patient's reward from one of the rewards present in the rewarddatabase 214. If a patient's reward is “pre-selected” by the patient, byan insurance company or by a medical professional, the patient database210 may include a field for each patient record that identifies thereward (e.g., by the reward ID 512) selected by or for the patient.

The compliance database 216 contains information related to at least onelevel to which a patient has complied with a schedule for takingmedicines. FIG. 6 illustrates a sample of the contents of the compliancedatabase 216. As shown in FIG. 6, the compliance database 216 containscompliance information for three patients identified in record 602,record 604 and record 606, respectively (e.g., the patients identifiedin records 302-306 of the patient database 210). Specifically, thecompliance database 216 contains records having fields corresponding to,for example, (1) a patient identifier (ID) 608 for each patient; (2) atime 610 by which the controller 106 is to receive (e.g., from eachpatient) a code that identifies at least one of whether the patient hascomplied with a schedule for taking medicines and whether the patienthas satisfied a proximity requirement for two or more medicinecontainers configured in accordance with the present invention so thatthe two or more medicine containers may communicate; (3) a time 612 thatidentifies when a code was received for/from each patient; (4) a codestatus 614 that identifies whether a code was received for each patient,whether the patient has complied with a schedule for taking medicines(e.g., as determined by the controller 106 based on the received code)and/or a compliance level for the patient; and (5) a reward ID 616 thatidentifies a reward selected for each patient (e.g., selected by thepatient, by an insurance company or by a medical professional). In thecompliance database 216 of FIG. 6, the reward ID 616 of each record602-606 is one of the reward identifiers specified in the rewarddatabase 214.

Exemplary Embodiments for the Compliance Monitoring Device 102

FIG. 7A is a schematic diagram of an exemplary embodiment of thecompliance monitoring device 102 of FIG. 1B wherein the compliancemonitoring device 102 is a medicine container 102 a. For convenience,the exemplary embodiment of the compliance monitoring device 102 of FIG.1B is referred to herein by reference numeral 102A in FIG. 7A; and onlythe relevant portions of the compliance monitoring device 102A (e.g.,the portions of the compliance monitoring device 102A associated withincreasing/monitoring compliance) are described herein. The compliancemonitoring device 102A may be implemented as a system controller, as adedicated hardware circuit, as an appropriately programmed generalpurpose computer, or as any other equivalent electronic, mechanical orelectromechanical device.

The compliance monitoring device 102A comprises a processor 702, such asone or more conventional microprocessors (e.g., one or more Intel®Pentium® processors). The processor 702 is in communication with atransceiver 704 through which the processor 702 communicates with otherdevices (e.g., the controller 106, the medicine containers 110, 112 and114, etc.). The processor 702 also is in communication with a display706. The transceiver 704 may include multiple communication channels forsimultaneous communication with the controller 106, and/or with themedicine containers 110, 112 and 114.

The processor 702 also is in communication with a data storage device708. The data storage device 708 may comprise an appropriate combinationof magnetic, optical and/or semiconductor memory, and may include, forexample, Random Access Memory (RAM), Read-Only Memory (ROM), a compactdisc and/or a hard disk. The processor 702 and the data storage device708 each may be, for example, located entirely within a single computeror other computing device; or connected to each other by a communicationmedium, such as a serial port cable, a telephone line or a radiofrequency transceiver. Alternatively, the compliance monitoring device102A may comprise one or more computers that are connected to a remoteserver computer (not shown) for maintaining databases.

The data storage device 708 may store, for example, (i) a program 710(e.g., computer program code and/or a computer program product) adaptedto direct the processor 702 in accordance with the present invention,and particularly in accordance with the processes described in detailhereinafter with regard to the compliance monitoring device 102A; and(ii) a container database 712 adapted to store proximity information andcompliance information regarding each medicine container employed withinthe novel compliance system 100 (e.g., the compliance monitoring device102A/medicine container 102 a and the medicine containers 110, 112 and114 in FIG. 1B).

The program 710 may be stored in a compressed, in an uncompiled and/orin an encrypted format. The program 710 also may include programelements such as an operating system, a database management system and“device drivers” that allow the processor 702 to interface computerperipheral devices (e.g., a video display such as the display 706, akeyboard, a mouse, etc.).

Note that instructions of the program 710 may be read into a main memory(not shown) of the processor 702 from a computer-readable medium otherthan the data storage device 708, such as from a ROM or from a RAM.While execution of sequences of instructions in program 710 causesprocessor 702 to perform the process steps described herein, hard-wiredcircuitry may be used in place of, or in combination with, softwareinstructions for implementation of the processes of the presentinvention. Thus, embodiments of the present invention are not limited toany specific combination of hardware and software.

The compliance monitoring device 102A (and/or the other medicinecontainers 110-114) also may be provided with a local positioning system714 (shown in phantom), such as a global positioning system (GPS), thatallows the compliance monitoring device 102A to track the distance ordistances between each medicine container and/or to help the patient 104locate one or more of the medicine containers as described furtherbelow. For example, each medicine container may track its own locationusing the local positioning system 714, and the tracked locationinformation for each medicine container may then be synchronized (e.g.,by the compliance monitoring device 102A or by controller 106) todetermine when/if the medicine containers were separated.

The processor 702 also may be in communication with a clock (not shown)that supplies time and date information to the processor 702 and thatmay comprise, for example, a clock internal to the processor 702, aclock external to the processor 702 or a clock embodied within theprogram 710 (e.g., based on a system clock not shown).

Note that each of the medicine containers 110-114 may be similarlyconfigured to the compliance monitoring device 102A of FIG. 7A (e.g., asa medicine container that is configured to operate both as a medicinecontainer and as a compliance monitoring device). In this manner, any ofthe medicine containers 102 a, 110, 112 and 114 may serve as acompliance monitoring device. Alternatively, the medicine containers110-114 may include a subset of the components and/or of the features ofthe compliance monitoring device 102A of FIG. 7A. For example, eachmedicine container 110-114 may be provided with the processor 702, thetransceiver 704, the display 706, the data storage device 708 and/or thelocal positioning system 714 for (1) monitoring whether a portion of amedicine stored within the medicine container was removed from themedicine container; (2) communicating with other medicine containersand/or with the compliance monitoring device 102A (e.g., forcommunicating when a portion of the medicine stored within the medicinecontainer has been taken by the patient 104, for receiving remindersabout when to take or not to take the medicine stored within themedicine container, etc.); (3) displaying warnings and/or reminders tothe patient 104 regarding the taking of the medicine stored within themedicine container; and (4) tracking the location of the medicinecontainer. U.S. Pat. No. 5,852,590 to de la Huerga, which is herebyincorporated by reference herein in its entirety, discloses methods ofdisplaying messages on a cap of a container. These methods may beemployed with the medicine containers of the present invention. Otherfunctions also may be performed (described below). For example, eachmedicine container may be programmed with all of the informationnecessary for the medicine container to be “self-regulating” (e.g., bycommunicating with other medicine containers). That is, in at least oneembodiment of the invention, each medicine container 102 a, 110, 112 and114 may communicate information to other medicine containers thatindicates when medicine was removed from the medicine container, eachmedicine container may receive information that indicates when medicinewas removed from other medicine containers, and each medicine containermay determine, based on a schedule for taking medicines and/or based onincompatibility information about medicines stored within the medicinecontainer's container database 712, whether a party should take amedicine stored within the medicine container. For “self-regulating”medicine containers, the controller 106 may track the patient 104'scompliance to a medicine schedule merely by monitoring whether themedicine containers 102 a, 110, 112 and 114 are being kept together.

FIG. 7B is a schematic diagram of an exemplary embodiment of thecompliance monitoring device 102 of FIGS. 1C-1D wherein the compliancemonitoring device 102 is a central monitoring device (e.g., themeta-container 102 b of FIG. 1C or the mini-container 102 c of FIG.1D)). For convenience, the exemplary embodiment of the compliancemonitoring device 102 of FIGS. 1C-1D is referred to herein by referencenumber 102BC in FIG. 7B, and only the relevant portions of thecompliance monitoring device 102BC are described herein.

With reference to FIG. 7B, the compliance monitoring device 102BC is incommunication with the four medicine containers 102 a, 110, 112 and 114.In at least one embodiment, the compliance monitoring device 102BC maycommunicate with any number (e.g., one, two, three or four) of themedicine containers as the medicine containers may communicate relevantinformation between one another (e.g., information such as when amedicine was removed from a medicine container, how much medicine wasremoved from the medicine container, etc.). The compliance monitoringdevice 102BC may communicate with one or more of the medicine containers102 a, 110, 112, and 114 via any communications mechanism (e.g., via awireless channel, via an electrical or optical connection, etc.). In theembodiment of FIG. 7B, the compliance monitoring device 102BC isconfigured similarly to the compliance monitoring device 102A of FIG.7A. That is, the compliance monitoring device 102BC of FIG. 7B includesthe processor 702, the transceiver 704, the display 706, the datastorage device 708, the program 710 and the container database 712. Thecompliance monitoring device 102BC of FIG. 7B therefore may communicatewirelessly with the medicine containers 102 a, 110, 112 and 114 via thetransceiver 704.

A sample of the contents of a container database record 712 a of thecontainer database 712 of FIGS. 7A and 7B is shown in FIG. 8. Thespecific data and fields illustrated in FIG. 8 represent only oneembodiment of the records stored in the container database 712 of theinvention. The data and fields of this database can be readily modified,for example, to include more or fewer data fields. A plurality ofdatabases also may be employed to store the data and fields.

With reference to FIG. 8, the container database record 712 a containsinformation related to a schedule for taking medicines, and variouscompliance/proximity information. Specifically, the container databaserecord 712 a contains, for example,: (1) a patient ID sub-record 802that identifies the patient associated with the container databaserecord 712 a (e.g., patient ID P-123-45-6789 that identifies Jane Doe asshown in the patient database 210 of the controller 106 of FIG. 3); (2)a container ID sub-record 804 that identifies the medicine containerassociated with the container database record 712 a (e.g., container ID:C-562-891 that identifies medicine container 102 a (FIG. 1B)); (3) aprescription ID sub-record 806 that identifies the medicine storedwithin the medicine container identified by the container ID sub-record804; (4) a prescription rules sub-record 808 that identifies a schedulefor taking the medicine identified by the prescription ID sub-record 806(e.g., one pill taken three times a day at six hour intervals); (5) adate/time sub-record 810 that identifies the time period covered by thecontainer database record 712 a; and (6) compliance sub-records 812-826that identify compliance/proximity information regarding the taking ofthe medicine identified in the prescription ID sub-record 806 relativeto the medicine in the other medicine containers (e.g., the medicinecontainers 110-114).

Each compliance sub-record 812-826 has fields corresponding to, forexample, (1) a container ID 828 that identifies a medicine container forwhich compliance/proximity information is stored in the compliancesub-record; (2) a prescription ID 830 that identifies the medicinestored within the medicine container identified by the container ID 828of the compliance sub-record; (3) rules 832 that identify conditions fortaking the medicine identified by the prescription ID sub-record 806relative to the taking of the medicine identified by the prescription ID830 of the compliance sub-record (e.g.,−2 hours indicates that themedicines cannot be taken within 2 hours of one another, +2 hoursindicates that the medicines must be taken within 2 hours of oneanother, etc.); (4) a rules compliance indicator 834 that indicates alevel of compliance to the rule 832 (e.g., 100%, 80%, 10%, etc.) of thecompliance sub-record; (5) a proximity start time 836 that identifies atime when the medicine container identified in the container IDsub-record 804 and the medicine container identified by the container IDsub-record 828 of the compliance sub-record are sufficiently proximateto allow the two containers to wirelessly communicate; (6) a proximityend time 838 that identifies a time when the medicine containeridentified in the container ID sub-record 804 and the medicine containeridentified by the container ID sub-record 828 of the compliancesub-record are no longer sufficiently proximate to allow the twocontainers to wirelessly communicate; and (7) a proximity complianceindicator 840 that indicates a level of compliance by the patientidentified in the patient ID sub-record 802 to a “proximity requirement”of the novel compliance system 100 (e.g., a pre-determined duration oftime that medicine containers must be positioned sufficiently proximateto one another to allow wireless communications between the medicinecontainers, a predetermined duration of time beyond which medicinecontainers cannot be separated sufficiently so as not to wirelesslycommunicate, etc.). For example, assuming that the proximity requirementof the novel compliance system 100 is that medicine containers cannot beseparated for more than 15 minutes, FIG. 8 illustrates that during thetime period from 00:00 to 14:00, the container C-562-891 and thecontainer C-152-906 were able to communicate for all but 5 minutes.Accordingly, the proximity compliance indicator 840 is 100% for thistime period (e.g., as indicated by sub-records 812 and 814). However,from 14:00 to 14:30, the container C-562-891 and the container C-152-906were unable to communicate (e.g., for 30 minutes) so that the proximitycompliance indicator 840 is reduced for this time period (e.g., to 85%as indicated by sub-record 816).

Note that the rules 832 (and any proximity requirements of the novelcompliance system 100) may be embodied within computer program code ofthe program 710 rather than being contained within the containerdatabase 712. Further, in embodiments wherein proximity information,rather than compliance information, is sent to the controller 106 (asdescribed below), the compliance monitoring device 102 need not computecompliance data and the container database 712 need not store compliancerules and/or compliance information.

Other information which may be stored within the container database 712or within any other database of the compliance monitoring device 102 ofFIGS. 7A and 7B includes, for example,:

-   -   (1) the identity of each medicine (e.g., the medicine's generic        name, the medicine's brand name, an identifying code for the        medicine, etc.);    -   (2) the name of the pharmaceutical company that manufactures        each medicine;    -   (3) any other relevant prescription information (e.g., the time        of day the medicine should be taken, the number of times a day        the medicine should be taken, whether the medicine should be        taken with food, the appropriate dose of the medicine to be        taken, a time interval the patient should wait between doses, a        duration of time the patient should take the medicine, etc.);    -   (4) the purpose of each medicine (e.g., to lower blood pressure,        to thin the blood, to lower cholesterol, to reduce depression,        etc.);    -   (5) interactions of each medicine with other medicines (e.g.,        other medicines that are part of a medicine schedule of the        patient, whether the interactions are adverse or synergistic,        etc.);    -   (6) the cost of each medicine; and    -   (7) the amount of each medicine that was dispensed to the        patient (e.g., the number of pills, the net weight of the        dispensed medicine, etc.).        Exemplary Operations of the Novel Compliance System 100

FIG. 9 is a flow chart of a first exemplary process 900 of the novelcompliance system 100 of FIGS. 1A-8, useful in describing the generaloperation of the novel compliance system 100. The specific operations ofthe compliance monitoring device 102 and of the controller 106 aredescribed below with reference to FIGS. 10-11 and FIGS. 12-13,respectively.

With reference to FIG. 9, the first exemplary process 900 begins in step902 when the patient 104 obtains two or more medicine containers each ofwhich: (1) is capable of wirelessly communicating with another medicinecontainer; (2) stores a medicine; and (3) is programmed with informationregarding the medicine stored within the medicine container (e.g., withany or all of the information in the container database 712 describedpreviously with reference to FIGS. 7A-8 such as a patient ID, acontainer ID, a prescription ID, prescription rules, etc.). The medicinecontainers may comprise, for example, the medicine containers 102 a,110, 112 and 114 (FIGS. 1B-1D).

The patient 104 may obtain the medicine containers by purchasing themedicine containers (together with or separately from each medicine), orthe medicine containers may be obtained for “free” with the medicines(e.g., from an insurance company, from a manufacturer of the medicines,from a physician, from a pharmacist, etc.). If the medicines are“prescribed” to the patient 104, a pharmacist, a physician or any otherauthorized person may provide each medicine container and/or eachprescribed medicine to the patient 104. Non-prescription medicines maybe similarly obtained and stored within one or more of the inventivemedicine containers. If the novel compliance system 100 employs acentral monitoring device (such as the meta-container 102 b or themini-container 102 c as described previously with reference to FIG. 7B),an insurance company, a pharmacist, and/or a physician, may provide thepatient 104 with the central monitoring device.

The medicine containers and/or the central monitoring device may beprogrammed by any known mechanism and by any party (e.g., by aninsurance company, by a physician, by a pharmacist, by the patient,etc.). For example, the program 710 (FIG. 7A) of each medicine containermay contain computer program code that directs the processor 702 toemploy the transceiver 704 so as to receive information required tocomplete one or more container database records 712 a for the medicinecontainer and that directs the processor 702 to generate and store theone or more container database records 712 a within the containerdatabase 712 of the medicine container. A central monitoring device maybe similarly programmed (if employed). Any other mechanism may be usedto program the medicine containers (and/or the central monitoringdevice) such as a keyboard, a keypad, a touch screen on the display 706,an infrared (IR) port, a bar code scanner, etc. Programmable labelssimilarly may be employed to store medicine information (see, forexample, previously incorporated U.S. Pat. No. 5,852,590 to de la Huergaand U.S. Pat. No. 5,963,136 to O'Brien which is hereby incorporated byreference herein in its entirety).

After the medicine containers have been obtained, in step 904,information required by the controller 106 to monitor compliance of thepatient 104 to a schedule for taking the medicines is provided to thecontroller 106. Exemplary information which may be provided to thecontroller 106 includes but is not limited to:

-   -   (1) the identity of each medicine (e.g., the medicine's generic        name, the medicine's brand name, an identifying code for the        medicine, etc.);    -   (2) the name of the pharmaceutical company that manufactures        each medicine;    -   (3) the prescribed method for taking each medicine (e.g., the        time of day the medicine should be taken, the number of times a        day the medicine should be taken, whether the medicine should be        taken with food, the appropriate dose of the medicine to be        taken, a time interval the patient should wait between doses, a        duration of time the patient should take the medicine, etc.);    -   (4) the purpose of each medicine (e.g., to lower blood pressure,        to thin the blood, to lower cholesterol, to reduce depression,        etc.);    -   (5) interactions of each medicine with other medicines (e.g.,        other medicines that are part of a medicine schedule of the        patient, whether the interactions are adverse or synergistic,        etc.);    -   (6) the cost of each medicine;    -   (7) the amount of each medicine that was dispensed to the        patient (e.g., the number of pills, the net weight of the        dispensed medicine, etc.);    -   (8) the identity of the patient, the identity of the prescribing        party and/or the identity of the party filling the prescription;    -   (9) the medical history of the patient (e.g., so that patient        specific warnings may be provided, including warnings that the        patient is allergic to certain medicines, that the patient is        pregnant and should not take one or more medicines, that the        patient is a child and should not take an adult dose, etc.);    -   (10) the number of medicines that the patient has been        prescribed (e.g., when each medicine container is programmed        with all of the information necessary for the medicine container        to be “self-regulating” by communicating with other medicine        containers, to track compliance, an insurance company may need        to track only that all the medicine containers are being kept        together); and    -   (11) information regarding non-prescription medicines taken by        the patient (e.g., as herbal remedies such as St. John's Wort        may interact with prescription medicines, reduce the        effectiveness of prescription medicines, and/or cause adverse        reactions).

The above information may be provided to the controller 106 by anymethod. For example, if an insurance company employs the controller 106and if the patient 104 is a member of the insurance company's compliancerewards program, the patient 104 may present a card to a pharmacist tonotify the pharmacist that information regarding any prescription filledby the pharmacist should be sent to the insurance company.Alternatively, information regarding the medicines may be provided tothe controller 106 by the patient 104 (e.g., the patient may submit aclaim to the insurance company in order to receive payment for theprescribed medicines and the insurance company may obtain informationregarding the medicines from the submitted claim).

Specific information about medicines also may be obtained by thecontroller 106 from various reference sources (e.g., from a WEB site,from a reference book, from a manufacturer's specification sheet, etc.).In an embodiment wherein the controller 106 is not operated by aninsurance company (e.g., when the controller 106 forms part of anauthentication server that may, for example, collect and authenticatecompliance data and provide the authenticated compliance data to aninsurance company), the controller 106 may receive information regardingthe medicines from an insurance company.

The medicine containers may send information to the controller 106, asmay a compliance monitoring device. For example, if a patient employs ameta-container 102 b (FIG. 1C) with the medicine containers, themedicine containers may “log in” to the controller 106 (e.g., dial in tothe controller 106) and relay information to the controller 106 when themedicine containers are placed in the meta-container 102 b. In general,any mechanism and any medium may be employed to send the information tothe controller 106 (e.g., a telephone connection, a radio link, akeypad, an Internet connection, a facsimile machine, etc.).

Once the controller 106 has received the above described information, instep 906 the compliance monitoring device 102 monitors the proximity ofthe two or more medicine containers (e.g., the compliance monitoringdevice 102 determines whether the at least two medicine containers aresufficiently proximate to wirelessly communicate). For example, thecompliance monitoring device 102 may poll the medicine containers, themedicine containers may periodically transmit signals to the compliancemonitoring device 102, etc.

In step 908, based on the monitored proximity information, thecompliance monitoring device 102 provides (e.g., directly or via thepatient 104) the controller 106 with at least an indicator of a level towhich the patient 104 has complied with a schedule for taking themedicines stored within each medicine container (e.g., a “complianceindicator”). As will be described further below with reference to FIGS.10-13, the compliance indicator that the compliance monitoring device102 provides to the controller 106 may be, for example, (1) informationregarding the proximity of the medicine containers (e.g., the times themedicine containers were separated and could not communicate, the timesthe medicine containers were together and could communicate, etc.); (2)one or more levels to which the patient 104 has complied with aproximity requirement for the medicine containers (e.g., a proximityrequirement set by an insurance company, by the controller 106, by anauthentication server, etc., such as a pre-determined, maximum timeperiod that the medicine containers may be separated) as determined bythe compliance monitoring device 102; (3) information regarding themedicines taken by the patient (e.g., the amount of each medicine takenby the patient 104, the time each medicine was taken by the patient,etc.); and/or (4) one or more levels to which the patient 104 hascomplied with one or more schedules for taking the medicines storedwithin the medicine containers (e.g., a level to which the patient 104has complied with a schedule for taking each medicine, a level to whichthe patient 104 has complied with a schedule for taking multiplemedicines, etc.) as determined by the compliance monitoring device 102.

Note that the specific compliance indicator provided by the compliancemonitoring device 102 to the controller 106 may affect the informationthat is stored by the compliance monitoring device 102 and/or by thecontroller 106. For example, if the compliance monitoring device 102merely provides the controller 106 with information regarding theproximity of the medicine containers, the container database 712 of thecompliance monitoring device 102 need not store information such ascompliance requirements (e.g., sub-record 832), compliance levels (e.g.,sub-records 834 and 840), etc. However, if the compliance monitoringdevice 102 provides the controller 106 with one or more levels to whichthe patient 104 has complied with a schedule for taking medicines, thecompliance monitoring device 102 need not send to the controller 106much of the compliance information described previously with referenceto step 904 (e.g., as the controller 106 need not compute a level ofcompliance). Compliance levels (and exemplary methods for determiningcompliance levels) are described below with reference to FIG. 10.

In step 912, the controller 106 rewards the patient 104 based on theindicator of the level (or levels) of compliance provided by thecompliance monitoring device 102. For example, in exchange for complyingwith a medicine schedule or for complying with any proximityrequirements for the medicine containers, the patient 104 may receivelower insurance premiums, reduced insurance premiums or co-payments,etc., as described below with reference to FIGS. 12-13. Note thatdepending on the exact compliance indicator provided to the controller106, the controller 106 may be required to compute one or morecompliance levels based on the compliance indicator (e.g., based onproximity information, based on the times the patient 104 took one ormore medicines, etc.) before rewarding the patient 104 (as describedbelow).

First Exemplary Operation of the Compliance Monitoring Device 102

FIG. 10 is a flow chart of a first exemplary process 1000 by which thecompliance monitoring device 102 may monitor and track the compliance ofthe patient 104 to a schedule for taking medicines. The process 1000 andthe other processes described below with reference to the compliancemonitoring device 102 may be embodied within computer program code ofthe program 710 of the data storage device 708 and may each comprise acomputer program product. The process 1000 is described with referenceto FIGS. 1B-1D wherein the patient 104 is required to comply with aschedule for taking four medicines stored within the medicine containers102 a, 110, 112 and 114. It will be understood that the same process maybe employed whether the compliance monitoring device 102 is merely acentral monitoring device (e.g., a meta-container 102 b (FIG. 1C) or amini-container 102 c (FIG. 1D)) or a medicine container (e.g., themedicine container 102 a of FIG. 1B).

With reference to FIGS. 1B-1D and 10, the process 1000 begins in step1002 when the compliance monitoring device 102 collects data regardingthe patient 104's compliance with a schedule for taking the medicinesstored within the medicine containers 102 a, 110, 112 and 114 (e.g., thecompliance monitoring device collects “compliance data”). Specifically,the compliance monitoring device 102: (1) determines proximityinformation regarding the medicine containers 102 a, 110, 112 and 114;and (2) determines a level of compliance to the medicine schedule basedat least in part on the determined proximity information.

As stated previously with reference to FIGS. 7A and 7B, one type ofproximity information that may be obtained by the compliance monitoringdevice 102 is whether each medicine container 102 a, 110, 112 or 114 hasbeen moved beyond a range wherein the medicine container may communicatewith the other medicine containers (e.g., whether, for a pre-determinedamount of time, any of the medicine containers 102 a, 110, 112 or 114have been unable to wirelessly communicate). The proximity informationobtained by the compliance monitoring device 102 alternatively, oradditionally, may comprise, for example, (1) the times each medicinecontainer has been moved beyond a range wherein the medicine containermay communicate with the other medicine containers and/or with thecompliance monitoring device 102; (2) the number of times each medicinecontainer has been moved beyond a range wherein the medicine containermay communicate with the other medicine containers and/or with thecompliance monitoring device 102; and/or (3) the distance (or the changein the distance) between the medicine containers and/or the compliancemonitoring device 102 (e.g., as determined by the local positioningsystem 714 of each medicine container, by the strength of signalstransmitted between the medicine containers and/or the compliancemonitoring device 102, or by any other position (or relative position)determination mechanism).

Once the compliance monitoring device 102 obtains proximity informationregarding the medicine containers 102 a, 110, 112 and 114, thecompliance monitoring device 102 determines a level of compliance to themedicine schedule based at least in part on the proximity information.One method for determining a level of compliance is to identify (basedon the proximity information) whether, for a pre-determined time period,any of the medicine containers 102 a, 110, 112 or 114 were unable towirelessly communicate with one another (e.g., whether any of themedicine containers were “out of range” of one another). If any of themedicine containers were out of range of one another for longer than apre-determined time period (e.g., 15 minutes, 10 minutes, 5 minutes,etc.), the patient 104's compliance level may be reduced from 100% aspreviously described with reference to FIG. 8. Alternatively, oradditionally, an indication that the medicine containers were out ofrange of one another for longer than a pre-determined time period may bestored (e.g., within the container database 712 of the compliancemonitoring device 102).

The predetermined time period may be fixed (e.g., may be the same timeperiod for each medicine container) or may vary (e.g., may be differentfor one or more of the medicine containers). For example, apre-determined time period of 20 minutes may be assigned to a medicinecontainer that contains a powdered medicine that must be dissolved inwater and then consumed, while a pre-determined time period of 10minutes may be assigned to a medicine container that contains a chewablemedicine. A “refill” exception may be provided wherein proximityinformation is not collected or is ignored, or wherein the patient 104or some other party may notify the insurance company when a medicinecontainer is being refilled (e.g., at a pharmacy). In this manner, thepatient 104 is not penalized when one or more medicine containers areseparated for a legitimate reason.

Note that while a medicine container being out of range of one or moreother medicine containers and/or of the compliance monitoring device 102for longer than a pre-determined time period may be an indicator thatthe patient 104 has not complied with a medicine schedule, a medicinecontainer being out of range of one or more other medicine containersalso may indicate that the patient 104 is taking a medicine stored inthe out of range medicine container (e.g., depending on thecommunication range of the medicine containers). Accordingly, thefailure of the patient 104 to move a medicine container beyond the rangeof the other medicine containers (and/or the compliance monitoringdevice 102) may indicate that the patient 104 has not taken the medicinestored within the medicine container and may constitute a failure of thepatient 104 to comply with the medicine schedule (e.g., the compliancemonitoring device 102 may deem the patient to be in non-compliance ofthe medicine schedule).

In addition to determining compliance data based on proximityinformation, the compliance monitoring device 102 may determinecompliance data based on other measures of the patient 104′s complianceto the medicine schedule. For example, the compliance monitoring device102 may monitor (1) the amount of each medicine that has been taken bythe patient 104; (2) the timing of the taking of each medicine; (3)various physical indications of the patient 104 (e.g., the patient 104′sblood pressure, the patient 104′s heart rate, the patient 104′s bloodglucose level, etc.) that may indicate whether or not the patient 104has taken one or more medicines; and/or (4) any attribute that indicatesthe patient 104 has complied with a medicine schedule. For example, apressure sensor may be employed within the cap of each medicinecontainer 102 a, 110, 112 and 114 that identifies each time the cap isopened or closed (as described, for example, in previously incorporatedU.S. patent application Ser. No. 09/165,089, filed Oct. 1, 1998, whichis now U.S. Pat. No. 6,751,730 B1), and opened/closed information may betransmitted to the compliance monitoring device 102 or to one or more ofthe medicine containers. A weight sensor may be employed within the baseof each medicine container 102 a, 110, 112 and 114 that identifies theweight of the medicine stored within the medicine container, and weightinformation may be transmitted to the compliance monitoring device 102or to one or more of the medicine containers. Other suitable weightsensors are described in U.S. Pat. No. 5,014,798 to Glynn which ishereby incorporated by reference herein in its entirety. Aradio-frequency identifier (RFID) may be embedded within each medicine(e.g., in each pill), and each medicine container and/or the compliancemonitoring device 102 may be provided with an RF scanner that senses theRFIDs so as to identify when medicine is removed from a medicinecontainer (e.g., so as to count the number of pills taken by the patient104). After obtaining information regarding the amount of medicine takenby the patient 104 (by employing one or more of the above-describedtechniques), the compliance monitoring device 102 may determine a levelof compliance to the medicine schedule. The compliance monitoring device102 may determine a first compliance level based on proximityinformation (e.g., proximity information about the medicine containers102 a, 110, 112 and 114) and may determine a second compliance levelbased on medicine consumption information (e.g., the amount of medicinetaken by the patient 104). Alternatively, or additionally, thecompliance monitoring device 102 may determine a single, “composite”compliance level based on both proximity information and medicineconsumption information.

In addition to tracking the number of pills dispensed from each medicinecontainer, the compliance monitoring device 102 also may track thetimes/intervals at which the pills were dispensed. The number of pillsand the times/intervals at which the pills were dispensed may be stored(e.g., pill 1 was dispensed at 9:00 a.m., pill 2 was dispensed 1 hourafter pill 1, pill 3 was dispensed 1 hour after pill 2, etc.).Alternatively, the compliance monitoring device 102 may compare thenumber of pills and the times/intervals at which the pills weredispensed with a stored, prescribed schedule of taking the pills (e.g.,a schedule that states “take one pill at a time at one hour intervals”),and the compliance monitoring device 102 may store an indication thatthe first three pills were taken in compliance with the prescribedschedule (e.g., by storing an indicator within a register (not shown)).

After determining the compliance data, in step 1004, the compliancemonitoring device 102 stores the compliance data (e.g., within one ormore records of the container database 712 as described previously withreference to FIG. 8). Note that in at least one embodiment of theinvention, the compliance data need not be stored by the compliancemonitoring device 102, and may be output as described below withreference to step 1012 or encrypted and output as described below withreference to steps 1010 and 1012.

In step 1006, the compliance monitoring device 102 determines if thecompliance data needs to be output. For example, to allow the patient104 to qualify for a compliance rewards program, an insurance companythat employs the controller 106 may require that the patient 104communicate the compliance data to the insurance company on a periodicbasis (e.g., daily, weekly, monthly, etc.), after completing all or partof a medicine regime, or after some other demarcation. Accordingly, thecompliance monitoring device 102 may be programmed to automaticallyoutput compliance data (as described below with reference to steps 1008,1010 and 1012) or may output compliance data in response to an action ofthe patient 104 (e.g., the pressing of a button 118 as shown in FIG.1B). If the compliance monitoring device 102 determines that thecompliance data needs to be output (e.g., because of a schedule builtinto the program 710, because the patient 104 presses the button 118,because one or more of the medicine containers 102 a, 110, 112 and 114needs to be refilled, etc.), the process 1000 proceeds to step 1008;otherwise, the process 1000 returns to step 1002 to collect additionalcompliance data.

In step 1008, the compliance monitoring device 102 retrieves thecompliance data (e.g., one or more compliance levels) previously storedby the compliance monitoring device 102. For example, the compliancemonitoring device 102 may retrieve the rules compliance data 834, theproximity compliance data 840 and/or a combination thereof from thecontainer database 712 (FIG. 8). Thereafter, in step 1010, thecompliance monitoring device 102 encrypts the compliance data so as togenerate “a code” (e.g., one or more symbols that represent thecompliance data). The compliance data may be encrypted using any knownencryption algorithm (e.g., using a one-way hash function or using anyother encryption algorithm such as those described in Schneier, AppliedCryptography 2^(nd) Edition: protocols, algorithms, and source code inC, John Wiley & Sons, Inc. (1996).), and the resulting code may have apredetermined length, a set length or an undetermined length. Thecompliance data that is encrypted may be the stored compliance data(described above) or may be compliance data calculated from the storedcompliance data. For example, the compliance monitoring device 102 maymerely store proximity information and/or information regarding how muchof each medicine has been taken by the patient 104, without calculatingone or more compliance levels. Thereafter, in response to a trigger(e.g., the patient 104 pressing the button 118, one or more of themedicine containers 102 a, 110, 112 or 114 running out of medicine,etc.) or automatically (e.g., periodically such as every night, everyweek, etc.), the compliance monitoring device 102 may calculate one ormore compliance levels (e.g., a proximity compliance level, a compliancelevel for the amount of each medicine taken by the patient 104, etc.)based on the stored compliance data. Each compliance level may be based,for example, on an evaluation of the stored compliance data, and may benormalized to a compliance level scale (e.g., 1 to 100). Each compliancelevel may then be encrypted.

In step 1012, the compliance monitoring device 102 outputs the encryptedcode. The code may be output to the patient 104 (e.g., via a display 120as shown in FIG. 1B), or may be output directly to the controller 106.For example, the compliance monitoring device 102 may display the codeto the patient 104, and the patient 104 may provide the controller 106with the code during a telephone call (e.g., via a plain-old-telephoneservice (POTS) line, via a cellular network, via an Internet telephonecall, etc.), via standard or electronic mail or via the Internet. Thepatient 104 may send an image of the code (electronically, via standardmail, via facsimile, etc.) to the controller 106 (or to an insurancecompany that operates the controller 106). The image of the code may begenerated via conventional photography (e.g., and sent through standardmail or scanned into a computer and sent electronically) or may begenerated via digital photography (e.g., and sent electronically). Thepatient 104 also may capture the image on a networked video camera andmay send the captured image electronically. Likewise, the patient 104may call (e.g., via a telephone, via a cellular telephone, via anInternet telephone, etc.) the controller 106 (or an insurance companythat employs the controller 106) and may then press the button 118 onthe compliance monitoring device 102 so that the compliance monitoringdevice 102 emits a series of tones (e.g., dual tone multiple frequency(DTMF) signals) during the call that communicate the code to thecontroller 106(and/or to the insurance company). The communication ofthe code to the controller 106 may occur periodically, or at certainpredetermined times such as when a medicine container needs to berefilled, or at the end of a prescribed medicine regime. The patient 104may call the controller 106 (or the insurance company) and communicatethe code at an arbitrary time if desired.

The patient 104 alternatively, or additionally, may communicate the codeto a doctor or to some other medical personnel (e.g., to a nurse, to anintern, etc.) who can in turn communicate the code (or the underlyingcompliance data) to controller 106 (and/or to the insurance company). Inthis manner, a doctor may monitor the patient 104's compliance, maydetermine, for example, if any symptoms experienced by the patient 104are a result of non-compliance and otherwise may act accordingly (e.g.,notify the insurance company, revise the patient 104's medicineschedule, schedule a doctor's visit, etc.).

The compliance monitoring device 102 (or any of the medicine containers102 a, 110, 112 and 114) may have a direct connection to the controller106 (and/or to the insurance company) and may communicate the code viathe direct connection (e.g., the controller 106 may query the compliancemonitoring device 102 for the code, a networked video camera may capturean image of the code on the display 120 and transmit the image of thecode to the controller 106, etc.). In some embodiments, the compliancemonitoring device 102 may only encrypt compliance data and/or output acode that represents encrypted compliance data if one or more compliancelevels are satisfied by the patient 104.

Numerous alternative operations may be performed during the process1000. For example, each medicine container, rather than the compliancemonitoring device 102, may output a different code that corresponds tocompliance data associated with the medicine stored within the medicinecontainer; or each medicine container may output the same code thatcorresponds to combined compliance data for all of the medicines storedwithin the medicine containers 102 a, 110, 112 and 114. When thecompliance monitoring device 102 is a medicine container (such as themedicine container 102 a of FIG. 1B), only the medicine container thatcommunicates within the controller 106 (e.g., the “head” medicinecontainer) need output a code (e.g., the head medicine container mayoutput a different code for each medicine container that corresponds tocompliance data associated with the medicine stored within the medicinecontainer; or the head container may output a single code thatcorresponds to combined compliance data for all of the medicines storedwithin the medicine containers 102 a, 110, 112 and 114). A centralmonitoring device similarly may output a different code for eachmedicine container that corresponds to compliance data associated withthe medicine stored within the medicine container, or may output asingle code that corresponds to combined compliance data for all of themedicines stored within the medicine containers 102 a, 110, 112 and 114.

As described previously with reference to FIGS. 1C-1D and FIG. 7B,rather than (or in addition to) communicating with each other, themedicine containers 102 a, 110, 112 and 114 may communicate with acentral monitoring device such as the meta-container 102 b or themini-container 102 c. Alternatively, the central monitoring device maycomprise a pager-like device, a personal digital assistant (PDA), alaptop computer, a desktop computer, etc. When a central monitoringdevice is employed, the proximity requirement for the medicinecontainers may be that all of the medicine containers remain proximatethe central monitoring device (e.g., within a range that allows themedicine containers to communicate with the central monitoring device).The central monitoring device may then track when or if the medicinecontainers have been taken out of range of the central monitoringdevice. For example, each medicine container may have attached theretoan infrared (IR) or radio frequency (RF) tag (as is known in the art)that contains information that identifies the medicine stored within themedicine container. Alternatively, the patient 104 may be provided withtags to attach to the medicine containers (e.g., tags provided by aphysician, a pharmacist, a manufacturer of the medicines and/or aninsurance company). The patient 104 also may be provided with an IRscanner or with an RF scanner that can read the IR/RF tags when the tagsare within range of the scanner. When a portable central monitoringdevice is employed (e.g., the mini-container 102C of FIG. 1D) thepatient 104 may be able to separate (without being penalized) one ormore medicine containers from the remainder of the patient's medicinecontainers (e.g., if the patient needs to take some but not all of thepatient's medicines to work). The mini-container 102 c may be programmedwith the identity of the medicines that the patient needs throughout theday (e.g., all or a subset of the medicines stored within the medicinecontainers 102 a, 110, 112 and 114), and in at least one embodiment, themini-container 102 c can download prescription information andprescription compliance information from a main central monitoringdevice (e.g., from the meta-container 102 b of FIG. 1B).

As an example of the mini-container 102 c 's operation, with referenceto FIGS. 1D and 8, assume the patient 104 is required to take bothmedicines “R-102-365” (stored in medicine container 102 a) and medicine“R-198-342” (stored in medicine container 114), but that the medicine“R-198-342” and the medicine “R-102-365” cannot be taken within 2 hoursof one another. If the patient 104 takes medicine “R-102-365” at 7:00a.m. (just before leaving home for work), the patient 104 will need totake medicine “R-198-342” while the patient is at work. Accordingly, thepatient 104 places the medicine container 114 (which stores the medicine“R-198-342”), along with any other medicine containers having medicinesthat the patient 104 will take while at work, into the mini-container102 c. The mini-container 102 c and the meta-container 102 b (FIG. 1C)then communicate (e.g., wirelessly, via a cable, etc.) so as to transferat least an indicator to the mini-container 102 c that the patient 104took medicine “R-102-365” at 7:00 a.m. Thereafter, the patient 104separates the mini-container 102 c from the meta-container 102 b, andtakes the mini-container 102 c to work. If the patient 104 attempts totake the medicine “R-198-342” at 8:00 a.m., the mini-container 102 c mayissue a warning to the patient 104 that notifies the patient 104 thatthe medicine “R-198-342” should not be taken until at least 9:00 a.m.(e.g., at least 2 hours after the medicine “R-102-365” was taken). Themedicine container 114 also may be programmed so as not to open untilafter 9:00 a.m.

The mini-container 102 c also may record when the patient 104 takes themedicine “R-198-342”, how much of the medicine “R-198-342” the patient104 takes, etc., and may report this information to the meta-container102 b and to the mini-container 102 c when the meta-container 102 b andthe mini-container 102 c are positioned proximate one another.

Second Exemplary Operation of the Compliance Monitoring Device 102

FIG. 11 is a flow chart of a second exemplary process 1100 by which thecompliance monitoring device 102 may monitor and track the compliance ofthe patient 104 to a schedule for taking medicines. The second exemplaryprocess 1100 of FIG. 11 is similar to the first exemplary process 1000of FIG. 10. However, rather than storing and outputting compliance data(as is performed during the first exemplary process 1000), during thesecond exemplary process 1100, the compliance monitoring device 102stores and outputs only proximity information (e.g., informationregarding the proximity of the medicine containers 102 a, 110, 112 and114).

With reference to FIG. 11, the second exemplary process 1100 begins instep 1102 when the compliance monitoring device 102 collects informationregarding the proximity of the medicine containers 102 a, 110, 112 and114 (as previously described with reference to process 1000 and step1002). Once the compliance monitoring device 102 obtains proximityinformation regarding the medicine containers 102 a, 110, 112 and 114,in step 1104 the compliance monitoring device 102 stores the proximityinformation (e.g., within one or more records of the container database712 as described previously with reference to FIG. 8). Note that in atleast one embodiment of the invention, the proximity information neednot be stored, and may be output as described below with reference tostep 1112, or encrypted and output as described below with reference tosteps 1110 and 1112.

In step 1106, the compliance monitoring device 102 determines if theproximity information needs to be output. For example, an insurancecompany that employs the controller 106 may require that the patient 104communicate the proximity information to the insurance company on aperiodic basis (e.g., daily, weekly, monthly, etc.), after completingall or part of a medicine regime, or after some other demarcation.Accordingly, the compliance monitoring device 102 may be programmed toautomatically output proximity information (as described below withreference to steps 1108, 1110 and 1112) or may output proximityinformation in response to an action of the patient 104 (e.g., thepressing of the button 118 as shown in FIG. 1B). If the compliancemonitoring device 102 determines that the proximity information needs tobe output (e.g., because of a schedule built into the program 710,because the patient 104 presses the button 118, because one or more ofthe medicine containers 102 a, 110, 112 and 114 needs to be refilled,because of any of the reasons described previously with reference toprocess 1000 and FIG. 10, etc.), the process 1100 proceeds to step 1108;otherwise, the process 1100 returns to step 1102 to collect additionalproximity information.

In step 1108, the compliance monitoring device 102 retrieves theproximity information previously stored by the compliance monitoringdevice 102. For example, the compliance monitoring device 102 mayretrieve information regarding the times/duration each medicinecontainer was out of range of the other medicine containers and/or thecompliance monitoring device 102, the distance (or change in distance)between the medicine containers during a specific time period, etc.Thereafter, in step 1110, the compliance monitoring device 102 encryptsthe proximity information so as to generate a code. The proximityinformation may be encrypted using any known encryption algorithm (e.g.,a one-way hash function, etc.), and the resulting code may have apredetermined length, a set length or an undetermined length. Theproximity information that is encrypted may be the stored proximityinformation (described above) or may be proximity information calculatedfrom the stored proximity information (e.g., a calculated change indistance between medicine containers).

In step 1112, the compliance monitoring device 102 outputs the encryptedcode. The code may be output to the patient 104 (e.g., via the display120 as shown in FIG. 1B), or may be output directly to the controller106.

First Exemplary Operation of the Controller 106

FIG. 12 is a flow chart of a first exemplary process 1200 by which thecontroller 106 receives compliance data from the patient 104 (or fromthe compliance monitoring device 102) and rewards the patient 104 basedon the received information. The process 1200 and the other processesdescribed below with reference to the controller 106 may be embodiedwithin computer program code of the program 208 of the data storagedevice 206 and each may comprise a computer program product.

With reference to FIG. 12, the process 1200 begins in step 1202 when thecontroller 106 receives a code that represents compliance data collectedby the compliance monitoring device 102. In at least one embodiment ofthe invention, the code is sent to the controller 106 from the patient104 or from the compliance monitoring device 102 (in step 1012 ofprocess 1000 of FIG. 10). In general the code may be received from anyparty and/or from any device. For example, the code may be sent from aparty that prescribed one or more of the medicines stored within themedicine containers 102 a, 110, 112 and 114, from a party that filledone or more of the prescriptions for the medicines stored within themedicine containers 102 a, 110, 112 and 114, from a family member, etc.Likewise, a telephone, a personal computer, a PDA, a medicine container,a meta-container (e.g., the meta-container 102 b of FIG. 1C), amini-container (e.g., the mini-container 102 c of FIG. 1D), any otherdevice associated with one or more of the medicine containers, etc., maysend the code to the controller 106 via any communications medium (e.g.,via a telephone network, via the Internet, via a wireless network, via alocal area network, via a wide area network, via an intranet, via anextranet, via standard mail, via verbal communication, etc.). A centralauthentication server (e.g., another controller that authenticatescompliance information) also may send the code to the controller 106.

In step 1204, the controller 106 decrypts the received code to determinethe compliance data collected by the compliance monitoring device 102.The code may be decrypted by employing a decryption algorithm to recoverthe pre-encryption compliance data, or if the code was encrypted using aone-way function (e.g., a one-way hash function), rather than decryptingthe code, the controller 106 may compare the received code with at leastone code corresponding to an acceptable level of compliance. Asdescribed previously with reference to FIG. 10, the compliance dataoutput by the compliance monitoring device 102 (step 1012) comprises oneor more levels of compliance of the patient 104 (e.g., a level ofcompliance to a proximity requirement imposed by an insurance company, alevel of compliance to a schedule for taking multiple medicines, a levelof compliance to a schedule for taking one medicine, a composite levelof compliance, etc.). The code received by the controller 106alternatively (or additionally) may indicate proximity information orother compliance information that may be employed by the controller 106to compute a compliance level (as described below with reference to FIG.13).

In step 1206, the controller 106 evaluates the decrypted compliance datato determine at least one level of compliance of the patient 104 to amedicine schedule. As stated, the decrypted compliance data may alreadycomprise one or more compliance levels so that the controller 106 needmerely examine the decrypted code to determine the compliance level (orlevels). Alternatively, the decrypted code may represent a firstcompliance level based on proximity information regarding the medicinecontainers 102 a, 110, 112 and 114 and a second compliance level basedon the amount of medicine taken by the patient 104. The decrypted codealso may represent a single, “composite” compliance level based on bothproximity information and medicine consumption information.

Likewise, the code may provide any of the proximity and/or complianceinformation described previously with reference to the processes 1000and 1100 of FIGS. 10 and 11.

Each compliance level used by the controller 106 (and/or by the)compliance monitoring device 102 may be based on a gradated compliancescale (e.g., a scale from 1 to 10). Alternatively, each compliance levelmay be an indication that a patient is not compliant, somewhatcompliant, compliant, very compliant, extremely compliant, 86%compliant, etc. A compliance level also may be nothing more than anindication that a patient is “compliant” and “not compliant”.Additionally, a “strike” system may be employed for determining eachcompliance level. For example, the patient 104 may be able to accumulatethree “strikes” (e.g., three instances of non-compliance) before beingconsidered to be “not compliant” or before the patient 104's compliancelevel drops by any amount (e.g., drops by 10%). If the patient 104 isresponsible for communicating the code to the controller 106 (e.g., asshown in FIGS. 1B-1D), then whether the patient 104 communicates thecode as required (e.g., as the patient 104 may be required tocommunicate the code before a certain time, periodically, etc.) may havea bearing on the patient's compliance level. A compliance level may bedetermined based on a number of times a cap of a medicine container wasopened or closed within a predetermined time period (e.g., as this datamay indicate a number of times medicine within the medicine containerwas taken during the time period).

In step 1208, the controller 106 determines a reward for the patient 104based on the patient 104's compliance level (or levels); and in step1210 the controller 106 rewards the patient 104. Exemplary rewards forcompliance to a medicine schedule include a lower insurance premium, alower insurance deductible, a lower insurance co-payment, reimbursementfor the price of one or more medicines, a free office visit with adoctor (e.g., the doctor that prescribed the medicine schedule), entryin a sweepstakes, money, prizes, points (or some sort of alternativecurrency), discounts on products, coupons, etc.

In at least one embodiment, the reward may be chosen from a list ofavailable rewards, and the reward may be chosen by an insurance company(e.g., by the insurance company that employs the controller 106), by thepatient 104, by a doctor (e.g., by the doctor that prescribed one ormore of the medicines taken by the patient 104), etc. The reward may bechosen for the patient 104 based on the patient's prior compliancehistory. For example, if the patient 104 has a poor compliance history,the patient may be offered a larger reward (e.g., so as to provide agreater incentive for the patient 104 to comply).

The reward may be based on the patient's level of compliance. If thecontroller 106 employs a gradated compliance level scale, the offeredrewards may be similarly gradated (e.g., a patient having a compliancelevel of 86% may be rewarded with $86 out of a possible $100).Compliance levels may be divided into ranges and a patient may berewarded based on the range in which the patient's compliance levelfalls. For example, a 90%-100% compliance level may be rewarded by cash;a 75%-90% compliance level may be rewarded by a reduction in insurancepremiums; a 50%-75% compliance level may be rewarded by a sweepstakesentry; and a 50% or lower compliance level may not be rewarded. If thecontroller 106 employs a “binary” compliance level (e.g., wherein apatient either is in compliance or is not in compliance), a binaryreward scheme may be employed (e.g., wherein a patient is charged a $20insurance co-payment if the patient is not in compliance and a $2insurance co-payment if the patient is in compliance). A patient alsomay be penalized for non-compliance, and whether or not a patient is incompliance may depend on other factors (e.g., whether the patient usedbrand name or generic medicines).

Separate rewards may be provided for compliance with a proximityrequirement and for compliance with a requirement for taking medicines.For example, if a patient keeps all of the patient's medicine containerstogether at all times, but on several occasions neglects to take one ofthe medicines within one of the medicine containers, the patient mayreceive a reward (e.g., $50) for keeping the medicine containerstogether. However, if the patient had not failed to take the onemedicine (e.g., if the patient had complied with the patient'srequirement for taking medicines), the patient would have received anadditional reward (e.g., the patient's insurance premium would have beendecreased by $100). Any other rewards/rewarding schemes may be similarlyemployed, and in return for receiving a reward (or the right to receivea reward) for complying with a schedule for taking medicines, thepatient 104 may agree to pay for any illness resulting fromnon-compliance. Note that in general, and as stated previously, thecompliance monitoring device 102 need only track and provide proximityinformation regarding medicine containers to the controller 106 asdescribed below with reference to FIG. 13.

Second Exemplary Operation of the Controller 106

FIG. 13 is a flow chart of a second exemplary process 1300 by which thecontroller 106 receives proximity information from the patient 104 (orfrom the compliance monitoring device 102) and rewards the patient 104based on the received information. The second exemplary process 1300 ofFIG. 13 is similar to the first exemplary process 1200 of FIG. 12, withexception that proximity information is received by the controller 106(rather than compliance data as in the first exemplary process 1200).

With reference to FIG. 13, the process 1300 begins in step 1302 when thecontroller 106 receives a code that represents proximity informationcollected by the compliance monitoring device 102. In at least oneembodiment of the invention, the code is sent to the controller 106 fromthe patient 104 or from the compliance monitoring device 102 in step1112 of process 1100 of FIG. 11. In general the code may be receivedfrom any party and/or from any device (as previously described withreference to the process 1200).

In step 1304, the controller 106 decrypts the received code to determinethe proximity information collected by the compliance monitoring device102. The code may be decrypted by employing a decryption algorithm torecover the pre-encryption proximity information, or if the code wasencrypted using a one-way function (e.g., a one-way hash function),rather than decrypting the code, the controller 106 may compare thereceived code with at least one code corresponding to acceptableproximity information (erg., an acceptable duration of time the medicinecontainers were separated). The code received by the controller 106 mayinclude other information that may be employed by the controller 106 tocompute a compliance level such as, for example, (1) the amount of eachmedicine taken by the patient 104; (2) the time each medicine was taken;(3) various physical indications of the patient 104 (e.g., the patient104's blood pressure, the patient 104's heart rate, the patient 104'sblood glucose level, etc.) that may indicate whether or not the patient104 has taken one or more medicines; and/or (4) any other informationfor determining whether the patient 104 has complied with a medicineschedule.

In step 1306, the controller 106 evaluates the decrypted proximityinformation (and any other information provided with the proximityinformation) to determine one or more levels of compliance of thepatient 104 to a medicine schedule. For example, the controller 106 maycompare the received proximity information (or any other informationprovided with the proximity information) to information previously sentto the controller 106 (e.g., a prescribed method for taking eachmedicine or medicines, the purpose of each medicine, interactions ofeach medicine with other medicines, or other information sent to thecontroller 106 in step 904). Any of the previously described methods forcomputing one or more compliance levels may be employed by thecontroller 106 to determine one or more levels of compliance of thepatient 104.

In step 1308, the controller 106 determines a reward for the patient 104based on the patient 104's compliance level (or levels); and in step1310 the controller 106 (or an insurance company that employs thecontroller 106) rewards the patient 104.

The foregoing description discloses only exemplary embodiments of theinvention, modifications of the above disclosed apparatus and methodswhich fall within the scope of the invention will be readily apparent tothose of ordinary skill in the art. For instance, in at least oneembodiment of the invention, a group (e.g., a family) may “enroll” in aninsurance company's reward program. In order to be rewarded, all membersof the group must comply to a schedule for taking one or more medicines(e.g., each member of the group must comply to a medicine. schedule forthat member). In this manner, the members of the group may enforce eachother's compliance. In embodiments wherein a party must call in a code(e.g., a code that provides proximity information and/or compliancedata), each member of the group may call in the member's own code, or acomposite code may be generated for the entire group and the code may becalled in by one party. A multi-tiered reward program may be employedwherein each member of the group receives one reward for compliance tothe member's own medicine schedule/proximity requirement and a secondreward if the group as a whole is in compliance.

As stated, a central monitoring unit such as the meta-container 102 b,the mini-container 102 c, a patient's personal computer or laptopcomputer, etc., may be provided that can communicate with all of themedicine containers. In such an embodiment, each medicine container mayemploy only an inactive communication element (e.g., a memory devicethat stores information relating to the medicine stored within themedicine container). The stored information may include information suchas, for example, the number of times that a cap of the medicinecontainer was opened and/or closed, or other information gathered byvarious sensors on/in the medicine container. The central monitoringunit then may poll the memory device of each medicine container toreceive the information stored within each medicine container. Whether aproximity requirement of an insurance company is satisfied may bedetermined based on whether a plurality of medicine containers are“plugged-into” the meta-container 102 b or the mini-container 102 c.

Multiple central monitoring units may be employed such as multiple meta-and mini-containers 102 b, 102 c. Because some medicines may requirerefrigeration, it may not be possible to keep all medicine containerswithin communication range. Accordingly, a plurality of centralmonitoring units may be desirable (e.g., one central monitoring unitthat can be refrigerated and one central monitoring unit that can bestored within a medicine cabinet). Alternatively, a central monitoringunit may be provided with a refrigerated compartment for storingmedicines/medicine containers that require refrigeration.

Note that once a medicine container is empty, the medicine container maybe refilled (e.g., by a pharmacist), may be recycled and/or may bereprogrammed for a different medicine. For example, new datacorresponding to a different medicine may be written into the containerdatabase 712 of the medicine container.

In addition to determining information regarding the distances betweenmedicine containers, the local positioning system 714 (e.g., a globalpositioning system) of a medicine container may be employed to assistthe patient 104 in finding the medicine container (e.g., if the medicinecontainer is misplaced, if the patient needs quick access to themedicine container, etc.).

While the present invention has been described primarily with referenceto medicine containers such as pill bottles, it will be understood thatthe invention may be employed with other types of medicine containers.For example, one or more embodiments of the invention may be employedwith micro-needle based devices such as those manufactured by Kumetrix,Inc. of Union City, Calif. (see, for example, www.kumetrix.com).Micro-needle based devices are typically formed by semiconductor devicemanufacturing techniques, and are capable of delivering (e.g.,painlessly) medicines into a patient's blood stream and of sampling andmonitoring a patient's blood to detect, for example, glucose levels(e.g., for diabetics), lactate levels (e.g., so as to detect internalbleeding, trauma, shock, etc.), pesticide levels, nerve gas levels, etc.In accordance with one or more embodiments of the invention,micro-needle based devices may be provided that can, for example,: (1)wirelessly communicate with one another and/or with a central monitoringdevice (e.g., by providing each micro-needle based device with a passiveor active transceiver); (2) administer predetermined doses of medicineto a patient (e.g., by providing each micro-needle based device with oneor more pumps and/or reservoirs); (3) communicate to one another that adose of medicine has been administered to a patient; (4) monitor patientcompliance (e.g., sample blood of the patient to confirm that a dose ofmedicine was administered to the patient); (5) ensure that incompatiblemedicines are not administered (e.g., by communicating information aboutwhen medicine doses are to be or have been administered to a patientamongst the micro-needle based devices employed by the patient); and/or(6) perform any of the other features described previously withreference to FIGS. 1A-13.

The compliance monitoring device 102 may monitor the time that eachmedicine stored within one of the inventive medicine containers is to betaken (e.g., in compliance with a prescribed medicine schedule), and maycommunicate this information to the relevant medicine container so thatthe medicine container notifies the patient (e.g., via the display 120,via a light-emitting-diode (LED), via an audible tone, etc.,) that thepatient should take the medicine stored within the container. The amountof each medicine to be taken may also be identified (see, for example,medicine container 112 in FIG. 1B). Likewise, a medicine container may,based on medicine compatibility information stored within the medicinecontainer and/or within the compliance monitoring device 102, notify orwarn a patient that the patient should not take a medicine (e.g.,because the patient has already taken or is about to take anotherincompatible medicine). A notification that a medicine should or shouldnot be taken may be communicated by other mechanisms such as via a pageror by broadcasting the notification over a radio or a television.

Each medicine container that contains an incompatible medicine may“lock” to prevent access to the medicine stored within the medicinecontainer (e.g., until such a time that the patient may safely consumethe medicine). Medicine containers similarly may lock when medicinecontainers are out of range of one another. Previously incorporated U.S.Pat. No. 5,852,590 to de la Huerga discloses locking mechanisms that maybe employed with the medicine containers of the present invention. In atleast one embodiment of the invention, a medicine container may providean electrical shock to a patient if the patient attempts to open themedicine container at an inappropriate time (e.g., after taking adifferent,. incompatible medicine). In another embodiment, when medicinecontainers are out of range of one another, each medicine container maystill communicate with the central monitoring device 102 and/or with thecontroller 106 via a telephone network, via a cellular network, via theInternet or via an other communication means Further, each medicinecontainer may be configured so that the medicine containers “interlock”(e.g., to ensure that the containers remain proximate); and complianceto a proximity requirement may be monitored graphically and/or visually(e.g., by having a WEB-based camera that provides a video image of themedicine containers to the controller 106).

The patient's medical history may also be included in the informationthat is programmed into the medicine containers, the compliancemonitoring device 102 and/or the controller 106. Further, the medicinecontainers, the compliance monitoring device 102 and/or the controller106 may be configured to receive (e.g., wirelessly or by any othermeans) test results from separate monitoring devices (e.g., from anin-home monitoring kit that monitors a blood glucose level of a patient,from a pregnancy test that identifies whether a patient is pregnant,etc.). In this manner, the medicine containers, the compliancemonitoring device 102 and/or the controller 106 may determine, based atleast in part on the test results from a separate monitoring device,whether a party should or should not take a medicine. For example, if atest indicates that a patient is pregnant, one or more of the medicinecontainers may “lock” to prevent the patient from accessing one or moremedicines. The compliance monitoring device 102 also may communicate thetest results to a third party (e.g., an insurance company, a doctor, apharmacist, etc.).

If a patient employs a plurality of the inventive medicine containers, afirst of which stores a first medicine, a second of the medicinecontainers and/or the central monitoring device 102 may communicate witha doctor that prescribed the first medicine, with a pharmacy thatprovided the first medicine or with any other relevant party so as toprovide information regarding a second medicine stored within the secondmedicine container. For example, if a first medicine container thatcontains a first medicine prescribed by a first doctor is placedproximate a second medicine container that contains a second medicineprescribed by a second doctor, the first and the second medicinecontainers may communicate with one another (e.g., to exchangeinformation regarding the medicine stored within each medicine containeras previously described), the first medicine container may communicatethe presence of the second medicine to the first doctor, and the secondmedicine container may communicate the presence of the first medicinecontainer to the second doctor. Schedules for taking each medicine, thereason for prescribing each medicine and any other information also maybe communicated.

Note that if a patient fails to comply to a medicine schedule, the datasupplied to the controller 106 by the central monitoring device 102 maybe an alarm rather than compliance data (e.g., an alarm that indicatesthat the patient has overdosed). The receipt of an alarm by thecontroller 106 may trigger an emergency response (e.g., the controller106 may call an ambulance), or the controller 106 may issue a warning tothe patient and/or to the patient's doctor.

While the present invention has been described primarily with referenceto a “proximity requirement” for two or more medicine containers thatmay communicate wirelessly, it will be understood that an insurancecompany and/or some other relevant party similarly may impose a“communication requirement” that requires, for example, that two or moremedicine containers merely be capable of communicating with one anotherduring a pre-determined time period rather than be proximate oneanother. For example, medicine containers may be configured so as tocommunicate with one another via a telephone network such as a publiclyswitched telephone network (PSTN), via a cable network, via an intranet,via an extranet, via the Internet, via an Internet-based telephonenetwork, or via any other communication medium (e.g., a radio frequencylink, a microwave link, an optical link, etc.) that does not necessarilyrequire the medicine containers to be proximate one another.

Each medicine may have a priority ranking, so that if there areconflicting medicines, the medicine with the highest priority ranking isincorporated into a medicine schedule before any of the other medicines.For example, assume a patient is taking heart medicine, anti-nauseamedicine, and an anti-depressant medicine that are ranked 1, 2 and 3 inimportance, respectively. The heart medicine is to be taken every 3hours, the anti-nausea medicine is to be taken every 4 hours and theanti-depressant medicine is to be taken every 6 hours. The heartmedicine and the anti-nausea medicine cannot be taken together (e.g.,the patient should wait at least one hour after taking one of themedicine before taking the other medicine).

The patient starts by taking the heart medicine and the anti-depressantmedicine at 12:00 p.m. At 1:00 p.m., the patient takes the anti-nauseamedicine. At 3:00 p.m., the patient takes the heart medicine again. At5:00 p.m., the patient takes the anti-nausea medicine. At 6:00 p.m. thepatient takes the heart medicine and the anti-depressant medicine. At9:00 p.m., the patient should take both the heart medicine and theanti-nausea medicine; however, the heart medicine and the anti-nauseamedicine are incompatible. Because the heart medicine has the higherpriority, the medicine container that stores the heart medicine and/orthe medicine container that stores the anti-nausea medicine may indicateto the patient that the anti-nausea medicine is not to be taken at thistime, but that the heart medicine is to be taken at this time.Accordingly, the patient takes the heart medicine. Then at 10:00 p.m.,the anti-nausea medicine container indicates to the patient that thepatient should take the nausea medicine.

Accordingly, while the present invention has been disclosed inconnection with the exemplary embodiments thereof, it should beunderstood that other embodiments may fall within the spirit and scopeof the invention as defined by the following claims.

1. A compliance monitoring device comprising: a housing configured toremovably accommodate a plurality of medicine containers, each of saidmedicine containers being adapted to wirelessly communicate, between afirst medicine container and a second medicine container, distance datacorresponding to a distance between the first medicine container thesecond medicine container; a transceiver coupled to the housing forwireless communication with the plurality of medicine containers; aprocessor in communication with the transceiver; and a data storagedevice associated with the processor, the data storage device storing atleast one program for directing the processor to: wirelessly communicatewith each of the medicine containers; monitor removal of each of theplurality of medicine containers from the compliance monitoring device;monitor the return of each medicine container to the compliancemonitoring device; store container data in the data storage device thatcomprises at least one of communications data, removal data and returndata associated with each medicine container; and determine patientcompliance with at least one schedule for taking medicine based on thecontainer data.
 2. The compliance monitoring device of claim 1, furthercomprising a display to provide information to a patient.
 3. Thecompliance monitoring device of claim 1, further comprising a localpositioning system.
 4. The compliance monitoring device of claim 3,wherein the local positioning system is a global positioning deviceoperable to generate location data for each medicine container.
 5. Thecompliance monitoring device of claim 3, wherein the program includesinstructions for directing the processor to: generate distance datacorresponding to the a distance between a first medicine container andat least one of a second medicine container and the compliancemonitoring device; and store the distance data in the data storagedevice as a component of the container data.
 6. The compliancemonitoring device of claim 3, further comprising a display device, andwherein the program includes instructions for directing the processor toprovide position data to a patient on the display device.
 7. Thecompliance monitoring device of claim 1, further comprising at least onesensor for generating medicine container content data.
 8. The compliancemonitoring device of claim 7, wherein the sensor comprises at least oneof a pressure sensor, a weight sensor, and an RF scanner.
 9. Thecompliance monitoring device of claim 7, wherein the program includesinstructions for directing the processor to: determine medicinecontainer content data corresponding to how much medicine was removedfrom at least one medicine container; and store the medicine containercontent data associated with the at least one medicine container in thedata storage device as a component of the container data.
 10. Thecompliance monitoring device of claim 1, wherein the data storage deviceincludes at least one of a container database, a prescription database,a medicine database, a patient database, a rewards database, and acompliance database.
 11. The compliance monitoring device of claim 10,wherein the container database includes data comprising at least one ofpatient identifier data, medicine container identifier data,prescription data, schedule data for taking medicine, date and timedata, rules data, compliance data and proximity data.
 12. The compliancemonitoring device of claim 10, wherein the container database includesdata comprising at least one of pharmaceutical company identity data,medicine purpose data, medicine side effect data, medicine interactionsdata, medicine cost data, and medicine dispensing data.
 13. Thecompliance monitoring device of claim 1, wherein the housing isconfigured as at least one of a meta-container and a mini-container. 14.The compliance monitoring device of claim 1, further comprising a timingdevice associated with the processor for determining when pills aredispensed.
 15. A compliance monitoring device comprising: a housingconfigured to accommodate a plurality of medicine containers that areeach adapted to store medicine, and are each further adapted towirelessly communicate, between a first medicine container and a secondmedicine container, position data corresponding to a position betweenthe first medicine container the second medicine container; acommunication device coupled to the housing and adapted to wirelesslycommunicate with the plurality of medicine containers; a processorassociated with the communication device; and a memory associated withthe processor, the memory storing a computer program executable by theprocessor and including instructions to direct the processor to:communicate with the medicine containers; determine, based at least inpart on the communications, position data corresponding to whether afirst medicine container storing a first medicine was positioned towirelessly communicate with a second medicine container storing a secondmedicine; and generate patient compliance data based at least on theposition data.
 16. The compliance monitoring device of claim 15, whereinthe computer program further includes instructions executable by theprocessor and directing the processor to determine if at least one partycomplied with a schedule for taking at least one of the first medicineand the second medicine, based at least in part on the determination ofthe positions of the first and second medicine containers.
 17. Amedicine compliance system, comprising: a compliance monitoring deviceconfigured to accommodate a plurality of medicine containers that areeach adapted to store medicine, the compliance monitoring device alsoconfigured for interactions with a patient and a medicine provider; aplurality of medicine containers each configured for wirelesscommunication with each other and with the compliance monitoring device;a network configured to facilitate communications between at least amedicine provider and the compliance monitoring device; and a controllerconfigured for communications with the network and with the compliancemonitoring device, and wherein the compliance monitoring device furthercomprises a processor operable to: communicate with the medicinecontainers and to determine, based at least in part on thecommunications, position data corresponding to the proximity of a firstmedicine container storing a first medicine to at least one of a secondmedicine container storing a second medicine and the compliancemonitoring device; and generate patient compliance data based at leastin part on the position data.
 18. A method, comprising: communicatingproximity data between each of a plurality of medicine containers havingmedicine stored therein and a compliance monitoring device, theplurality of medicine containers each configured for communication witheach other and with the compliance monitoring device; monitoring removalof each medicine container from the compliance monitoring device;monitoring the return of each medicine container to the compliancemonitoring device; storing medicine container content data in a storagedevice of the compliance monitoring device; and determining, with thecompliance monitoring device, a level of patient compliance to at leastone medicine dispensing schedule based on at least the proximity data,the removal data, the return data and the medicine container contentdata.
 19. A non-transitory computer readable medium storing computerexecutable instructions for causing a processor to: communicateproximity data between each of a plurality of medicine containers havingmedicine stored therein and a compliance monitoring device, theplurality of medicine containers each configured for wirelesscommunication with each other and with the compliance monitoring device;monitor removal of each medicine container from the compliancemonitoring device; monitor the return of each medicine container to thecompliance monitoring device; store medicine container content data in astorage device of the compliance monitoring device; and determine, withthe compliance monitoring device, a level of patient compliance to atleast one medicine dispensing schedule based on at least the proximitydata, the removal data, the return data and the medicine containercontent data.